Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery

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Brief Title

Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery

Official Title

Clinical Trial on Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery: The Cochlea as a Capacitor

Brief Summary

      Hearing is the ability to perceive sounds through the ear. If the transmission of sound is
      defective, the person suffers some degree of hearing loss. Cochlear Implants (CI) provide
      partial hearing by stimulating auditory nerve cells.

      The evaluation of the functionality of the CI is facilitated by several analysis tools, such
      as the clinical calibration software. This offers the possibility of measuring electrical
      impedances in the cochlea. The electrical impedance is the opposition to the current flow
      between two electrodes. It is composed of two main elements: resistance and reactance. The
      impedances in a cochlear implant are not stable over time. The value is minimal immediately
      after surgery, and increases progressively in the first 2 to 3 weeks after the procedure due
      to the immune response of the organism against a foreign body and the trauma of the array
      insertion. Several authors have suggested the use of topical or intravenous corticosteroids
      to decrease intracochlear fibrosis. The use of Dexamethasone could have a protective effect
      by reducing the initial inflammatory response, apoptosis, and delayed fibrosis, which could
      impact the impedance.

      There is limited evidence on the effect of intra-surgical topical corticosteroids on the
      impedance of the cochlear implant.

      The aim of this clinical trial is to evaluate the impact of topical dexamethasone on the
      electrical impedance of the cochlear implant, with special attention to the analysis of the
      capacitive component. It will be carried out through an experimental, prospective, randomized
      and double-blind study.

      Objective To determine whether the use of topical dexamethasone in a single dose applied in
      the tympanic cavity (middle ear) during cochlear implant surgery modifies the capacitive
      component of the electrical impedance of the electrodes in the cochlea before the activation
      of the cochlear implant.

      Material and methods A phase 3 clinical trial will be conducted. The design is a parallel,
      randomized, controlled and double-blind experimental study.

      Expected impact The use of local dexamethasone during cochlear implant surgery would decrease
      the inflammatory response, improving postoperative impedances.
    

Detailed Description

      Hypothesis The use of topical dexamethasone in a single dose applied to the tympanic cavity
      during cochlear implant surgery modifies the capacitive component of the electrical impedance
      of the electrodes in the cochlea during the first days of the postoperative period.

      goals Primary objective To assess whether the use of topical dexamethasone in a single dose
      applied to the tympanic cavity (middle ear) during cochlear implant surgery, prior to the
      insertion of the electrode array in the cochlea modifies the capacitive component of the
      electrical impedance of the cochlear implant. electrodes in the cochlea before activation of
      the cochlear implant.

      Secondary objectives To assess the safety and efficacy of the use of topical dexamethasone in
      a single dose in the middle ear cavity during cochlear implant surgery.

      To estimate the capacitive component of the electrical impedance of the electrodes in the
      cochlea on a daily basis, from the day of surgery until the day of switching on, in two
      groups of patients: experimental and placebo.

      Materials and methods Design Phase 3 clinical trial design is an experimental parallel,
      randomized, controlled, double blind assess the effect of the use of topical corticosteroids
      on the electrical impedance of the electrodes in the cochlea after surgery will be performed
      of cochlear implant surgery.

      All patients diagnosed with severe to profound sensorineural hearing loss unilateral or
      bilateral that its pathogenesis and pathophysiology are considered candidates for cochlear
      implantation, will be evaluated as routine in our service, imaging, audiological and
      psychological studies. Accomplished and accepted the nomination for the placement of one or
      two cochlear implants will be offered the opportunity to participate in the protocol.

      Patients will be selected and those who accept the invitation to participate, the study will
      be randomly divided into two groups, an experimental group and a placebo group. Randomization
      was performed in balanced way with a 1: 1 ratio between the branches. The randomisation list
      will be in blocks of variable size between 2 and 6.

      We will proceed as usual to the cochlear implant surgery, using the same anesthetic
      technique, surgical approach and surgical procedure in any cochlear implant surgery.
      Technique worldwide known and accepted as "minimally traumatic cochlear implant surgery" (see
      section definitions below) is used.

      The two study groups are:

      Group Dexamethasone(DEX):topical administration of dexamethasone (20 mg / ml) in the eardrum
      of the middle ear through the back tympanostomy, single dose during cochlear implant surgery,
      prior to inserting the array of electrodes.

      Group Placebo / Solution Physiological(SF):topical administration of isotonic sterile
      physiological solution in the eardrum of the middle ear through the back tympanostomy,single
      dose during cochlear implant surgery, prior to insertion of the array of electrodes .

      After inserting the electrode array into the cochlea, proceed as usual measurements of the
      electrical responses Intraoperative routine and supplemented with the closure and local
      healing.

      From the date of the surgical procedure and until the final activation of the implant
      (usually 30 days), you will be asked the patient or family, you make two daily measurements
      of the impedances of the electrodes, for which he was trained during the hospitalization the
      day of surgery, the use of a simple software to be distributed for this purpose (CIDC -see
      later-). The software installed on the computer from the patient can communicate through the
      common communication interface Cochlear POD (used in clinical practice for starting and
      calibration of the cochlear implant by the audiologist) and a speech processor Cochlear
      Freedom (delivered consignment for the study) the implanted device (receiver-stimulator) in
      patient surgery.

      With this software data electrode impedance will be obtained twice a day, in different
      configurations stimulation and measurement, and will be sent automatically via Internet to a
      remote server managed by the authors of this protocol.

      Postoperative controls on floor and then not differ outpatient than usual for these
      procedures.

      Blind:blind will be maintained for this study the researcher, the patient, evaluation of
      results and analysts. The only not blind will be who prepares the medication from pharmacy.
      Electrical impedance measurements are automatic and blind although objective measurements are
      discussed.

      Blind opening procedure:opening blind held immediately in the event of occurrence of an intra
      or postoperative complication (eg intraoperative hemodynamic alteration, uncontrollable
      bleeding, infection, fever, allergic reaction, wound dehiscence). Similarly, the blind will
      be opened for the group of principal investigators, always after completing the stage of
      implementation of the protocol in patients in question, and each not less than 2 months and
      the sole purpose of making a partial analysis the results that may involve changing the
      acquisition parameters of samples for a better interpretation of the results and to fulfill
      the main objective stipulated.

      Place work Patients will be evaluated at the Department of Otolaryngology, Hospital Italiano
      de Buenos Aires as usual in this type of evaluation. Surgery is carried out in the central
      operating room of the hospital by any of the three surgeons otologists privileges for these
      procedures and not differ from the usual surgical technique for cochlear implantation. THe
      postsurgical controls will be performed in the same service by the same professionals.
      Measurements of proposals impedances are performed for the oun paciente or his parents, using
      the same technique and the same equipment used by Audiologists in visits calibration cochlear
      implants, with help of software designed by researchers specifically for this purpose. The
      data will be transferred remotely through a security protocol to a fund administered by the
      principal investigators (cloud) server. Further analysis of the data, evaluation of the
      results and conclusions of the work will be performed by the principal investigators of this
      protocol in the field of Hospital Italiano de Buenos Aires.

      Population All cochlear implant candidates who meet all inclusion criteria and no exclusion
      criteria patients and to accept participation in the protocol will be recruited.

      Note: If a patient is candidate for bilateral cochlear implant or for the duration of the
      study is candidate for reimplantation each ear will be considered separately. In this case
      each ear will be randomized separately following the same procedure.

      Definitions Gusher:outpour of perilinfa before the surgical opening of the inner ear.

      Minimally traumatic cochlear implant surgery:surgical procedure for placing an electronic
      implantable device to partially restore hearing function in patients diagnosed with severe
      sensorineural hearing loss to profound unilateral or bilateral that do not respond to other
      forms of hearing rehabilitation and meet medical, audiological, radiological and
      psychological criteria for cochlear implantation.

      Minimally traumatic surgical technique consisting placing the receiver-stimulator implant
      beneath the skin on the temporo-parietal region and an array of electrodes that must be
      positioned in the scala tympani of the cochlea, not generating any damage to structures level
      the outer and middle ear (tympanic membrane, middle ear bones) as well as minimum damage to
      the delicate microstructures inner ear, avoiding maneuvers abrupt opening of the inner ear,
      suction labyrinthine liquid inlet bone powder or blood the cochlea, and allowing the
      introduction of the electrode array into the cochlea very slowly, in the direction with
      better orientation and parallel basal turn the scala tympani.

      To do this, the procedure is performed under general anesthesia through a small incision,
      extending from the tip of the mastoid to temporo-parietal region. It said incision includes
      the skin, subcutaneous tissue, muscle and periosteum in the same line. A small
      postero-superior subperiosteal pocket where it will be hosted the receiver-stimulator implant
      is then generated; for which bone cutter in a small bowl of about 2 cm in diameter. Then a
      simple mastoidectomy is performed, exposing and preserving the anvil and the approach is
      completed with a posterior tympanotomy or approach to facial recess under monitoring of the
      facial nerve and preserving the structure. Ideally it identifies and preserves cord tympani
      nerve (anterior posterior limit of the tympanostomy). Through the latter the tympanic box is
      displayed and the round window niche (anatomical repair in relation to the scala tympani of
      the cochlea) is identified. Careful hemostasis is performed and the mucosa of the margins of
      the round window DeCola. Usually at this point is necessary and milling at low speed gently
      and above upper lip of said recess to allow better visualization of the round window membrane
      (eardrum side). At this point,is necessary for a thorough washing of entire surgical area in
      order to clear debris or blood bone powder. Then isotonic saline (SF group) or dexamethasone
      (DEX group) in the tympanic cavity through the posterior tympanotomy, taking special care to
      the round window membrane is completely submerged in the liquid instill. The implantable
      device (cochlear implant) is then placed and secured by a suture. At this time it will
      proceed to the delicate opening of the membranous labyrinth, either through the round window
      itself, through a small anterior and lower extension thereof or through a cochleostomy
      (anterior and inferior bone milling margins the round window), performing the endosteal and
      carefully opening the membranous labyrinth, with special emphasis on not allow entry of bone
      dust or blood, as well as preventing aspiration of labyrinthine fluid (perilymph). It shall
      then be slow and progressive introduction of the array of electrodes, with the technique
      described by the manufacturer as the electrode toused, CI512, CI522 and CI532, progressing
      the array in the right direction (tangential to the direction of the scala tympani at level
      of the basal turn of the cochlea) until the entire array of electrodes is positioned within
      the cochlea. To be completed by sealing the edges of the round window with a small piece of
      muscle, bone powder level back tympanostomy and finally rearranged the remaining wires in the
      mastoid cavity, avoiding excessive mobilization, fixing them with a piece of gel foam inside
      it. The layered closure, periosteum, muscle-fatty cellular and skin absorbable suture is
      completed. A local flat cure furacinada gauze and a bandage is made. He shall carry out the
      routine tests and neural response telemetry. End of the surgical procedure.

      Intervention Patients admitted with diagnosis of severe sensorineural hearing loss or
      profound unilateral or bilateral that are evaluated and meet the criteria for candidacy for
      cochlear implant and comply turn all the inclusion criteria and none of exclusion, will be
      invited to participate in the study.

      Accepted this, a randomized double blind study where the pharmacy is responsible for
      randomizing treatment among participants proposed subjects. Each of these activities will be
      properly recorded in writing.

      Then they are subjected to usual for placement cochlear implant according the technique of
      minimally traumatic cochlear implant surgery and used worldwide spread surgery. Reached the
      operating time in which the round window is displayed (reference anatomical structure of the
      inner ear and where (or margins) cochlear implant is usually introduced) will proceed as
      follows, identical in both groups Experimental (DEX) topical dexamethasone (Decadron shock
      are placed® laboratory Sidus)in concentration of 20mg / ml in single dose in the eardrum of
      the middle ear through posterior tympanostomy during cochlear implant surgery, taking special
      care that the membrane round window is completely submerged in the liquid, prior to insertion
      of the array of electrodes.

      Placebo group (SF):

      physiologic solution is placed isotonic sterile single dose in the eardrum of the middle ear
      through posterior tympanostomy during cochlear implant surgery, taking special care that the
      membrane of the round window is completely submerged in the liquid, prior to insertion of the
      array of electrodes.

      Pharmacy Hospital Italiano de Buenos Aires will be responsible for providing the drug and
      placebo. It handle it, receiving, contabilizándola, storing and delivering relieving against
      medical prescription. It will ensure that it is used solely for the purposes of the study.
      Each of the activities will be recorded in writing. Pharmacy Hospital Italiano de Buenos
      Aires (HIBA) is the only non blind study participant.

      After the surgical procedure, the patient remain hospitalized 24 hours as usual in this type
      of procedure. Finally cures and weekly inspections shall be made during the first month until
      activation of the implantable device and continue audiological rehabilitation therapy.

      From the day of surgery including, until day programmed for activating the implant, all
      patients enrolled the study (2 intervening groups) made identically and by themselves or by
      the help of a relative or guardian, measurements daily (morning and evening) of the
      impedances of the electrodes of the implant with the CIDC software (available free the day of
      surgery) and the communication interface POD through a speech processor Cochlear Freedom
      delivered on consignment during tests for such end.

      The result of the measurements of each patient will be sent automatically and as soon as
      become available internet connection, from the patient's own computer to a remote server
      (cloud) administered by researchers.

      The study ends on the final activation of cochlear implant (approximately 30 days after
      surgery), at which the implant is permanently connected by the audiologist to your speech
      processor and the items delivered on consignment for the study will be returned (POD
      communication interface and speech processor Cochlear Freedom).

      Sampling and sample calculation All patients who meet the inclusion criteria and no exclusion
      to participate in the study and these will be distributed in a randomized into one of two
      treatment arms will be invited. Monitoring each patient shall be performed within 30 days; it
      coincides with the usual postoperative controls first week and first postoperative month.

      The cochlea with fibrosis exhibit electrical impedance at about 20 KQ compared to a normal
      cochlea at the day of implant activation (approximately 30 days) 7 KQ with a common standard
      deviation of 1,481KΩ. To test the null hypothesis that the impedance is equal in patients who
      were administered steroids and those not were applied, with a power of 80% and an alpha of 5%
      to test two tailed required 10 patients per group.

      With the sample size reached 4980 capacitance values are obtained per patient (20 patients,
      with 22 electrodes each evaluated in four sequences impedances, with two daily measurements
      for 30 days). This sample size achieved in 10 patients per group is sufficient for the
      purpose of describing the behavior of the capacitive impedance component with and without
      corticosteroid over time.

      The sample calculation was performed using STATA 14.0 software and Power and Precision
      version 4.

      Implementation of the clinical

      The protocol is conducted in two stages:

      Stage 1: Validation "in silico" software to measure impedances. In order to obtain the
      samples needed to analyze and meet the objectives in this protocol, it is required perform in
      the patient impedances measurements through the implanted recent device. This is done
      conventionally in the clinic, by transient connecting a measuring coil which is coupled to
      implantable device, and through communication interface is integrated to a computer (in the
      same way that the audiologist makes calibrations sessions on and calibration). By suitable
      software, measurements can be obtained. However, given the cumbersome and likely poor
      adhesion to it if you consider that the patient must attend twice a day to treating facility
      during the first postoperative to make the necessary measurements month, the group of leading
      researchers this protocol devised and developed their own software that allows a safe,
      outpatient basis, and the patient's home, taking measurements by himself. In turn, the
      software in question should allow to measure with the stipulated parameters and the set
      sequences. The software, called "Cochlear Implant Data Collector (CIDC)" was developed
      specifically for the realization of this work (and possibly future) and validated by the
      authors. It is intended to be distributed for free, and installed on the computer from the
      patient to make measurements. Details thereof, its operation, validation and security are
      further described in Annex 3.

      Step 2: Patient inclusion. Surgery. Impedance measurement Inclusion of patients:Patients who
      are candidates for cochlear implantation unilateral or bilateral and that meet the selection
      criteria (see inclusion / exclusion). They explained the protocol and will be asked sign
      informed consent. It will notify the Hospital Italiano central pharmacy to incorporate the
      patient randomization and drug preparation / matching placebo for the day of surgery.

      Surgical procedure will proceed to the cochlear implant surgery according the conventionally
      accepted worldwide and known as classic description minimally traumatic cochlear implant
      surgery (see definitions section). As soon as the access to the tympanic cavity is achieved
      through the posterior tympanostomy and have identified the round window, proceed according
      the group randomized to placement or otherwise of the corresponding substance, instilling it
      directly through the posterior tympanotomy, to completely fill the tympanic cavity, taking
      special care that the secondary eardrum round window is immersed therein. Then continue with
      the milling of the bowl to the receiver-stimulator, a cochlear implant is placed in the bed,
      and slowly and continuously inserting the array of electrodes, either round window round
      window extended or cochleostomy in ramp will tympanic, according surgeon preference and
      judgment to meet the primary objective of minimally invasive approach controlling the
      insertion time in seconds. Finally closing the surgery is completed until completion. It
      shall then be measuring impedances and neural response as is customary in this procedure.

      Measurements using Software "Cochlear Implant Data Collector":out to bring the proposed
      objective of this study analysis was designed and validated "CIDC" software (see Appendix 3),
      whereby the patient perform every 12 hs about measurements of the impedances of the
      electrodes in the sequence routine and established for this purpose in the software.

      Sequences stimulation and measurement are as follows:

      Sequence1:this sequence involves the monopolar stimulation of each of the 22 intracochlear
      electrodes as cathode, with the two extracochlear electrodes reference: "Monopolar 1 + 2"
      (MP1 + 2) Mode (anode). During each stimulation was recorded by measuring the voltage
      obtained from the same electrode stimulated and reference electrodes in the 14 available time
      slots by the chipset cic4 implant. Thus 308 samples will be obtained.

      Sequence2:Mode "common ground" (CG): this sequence involves stimulation of each of the
      individual electrodes 22 as cathode, with reference (anode) to the rest of the array of
      electrodes. During each stimulation was recorded by measuring the voltage obtained between
      the same electrode and the remaining stimulated intracochlear electrodes in the 14 available
      time slots by the chipset cic4 implant. Thus 308 samples will be obtained.

      Sequence3:Mode "3 points" (3P): intracochlear electrodes will be stimulated sequentially from
      1 to 20 inclusive using the following logic: cathode electrode = 'n'; anode electrode = 'n +
      2'. Voltage between electrodes nn + 1 is recorded simultaneously at the 14 available time
      slots by the chipset cic4 implant. Thus 280 samples will be obtained.

      Sequence4:Mode "4 points" (4P): intracochlear electrodes stimulate sequentially 1 to 19
      inclusive using the following logic: cathode electrode = 'n'; anode electrode = 'n + 3'. The
      voltage between electrodes n + 1 and n + 2 in the 14 available time slots by the chipset
      implant cic4 be recorded simultaneously. Thus 266 samples will be obtained.

      In each sequence described above is used as stimulation parameters constant the following
      values:

      current level: 80 units of current (corresponding the data sheet chipset cic4 to 74.21 uA)
      Time between phases: 8 mS Period: 333.4 mS Pulse width : two sequences, 25 and 50 mS

      All the sequences described above are made using two different pulse widths predetermined
      stimulation 25 and 50 mS.

      To make these measurements, the company Cochlear LTD or his representative in the country
      (Tecnosalud SA) provided no cost, a Freedom ™ and an interface POD to connect to computer
      from the patient, where it install the software processor with a single executable
      distributed the day of surgery in a pendrive with the appropriate language (Spanish, English,
      German, Portuguese). All devices will be provided on loan for development work and will be
      returned to medical team on the day,date on which end data by the patient.

      All measured by the software and the context information values (especially the parameters
      used for each individual measurement and time) are stored in a local database. From the time
      the application performs periodic attempts to export the data to a database located on a
      server in the cloud. This database is capable of centralizing measurements unlimited
      patients. The server is managed and maintained by the principal investigators of this
      protocol.

      Statistical analysis The analysis will be performed by protocol and by intention to treat.
      The analysis unit be each patient into one of two treatment arms.

      Descriptive analysis of quantitative variables with mean and standard deviation or median and
      interquartile range as observed distribution is expressed. Categorical variables are
      expressed in proportion to confidence interval for the ratio.

      The effect of corticosteroid (dexamethasone) on the variable impedance and capacitance
      results with generalized equation estimated (GEE) measured. The natural grouping of the
      individual measurements and the times (panel data) are considered.

      Statistical analysis was performed using STATA version 14.0 software. They are considered
      statistically significant lower probability to 5%.

      Clinical management and neglect each patient autonomy be respected to discontinue treatment
      at any time by communicating to researchers.If the medical staff, researchers or the patient
      believe that the individual is at risk because the trial, the same will be withdrawn from the
      study and will explain the reasons why that decision is taken.

      Adverse events Adverse events were collected for each control and each time the patient
      contact the investigator. They are classified according the scale described by Dindo
      complications and Clavien in 2004 [24,25].Complications are described as deviations from
      normal postoperative, not including the consequences inherent the procedure itself.

      Complications grades are:

      Grade 0: no complications Grade I: Any deviation from the normal postoperative course that
      does not require pharmacological, surgical or endoscopic treatment and does not require
      radiological interventions. It included in this level using antinauseants, antipyretics,
      analgesics, diuretics, electrolytes and physiotherapy, as well as drainage of wound
      infections "bedside".

      Grade II: Requires pharmacological treatment with drugs not included in the grade, including
      transfusions and parenteral nutrition.

      Grade III: require surgical, endoscopic or radiological intervention treatment:

      IIIa:without general IIIb: anesthesia:general anesthesia Grade IV: life-threatening
      complication requiring handling unit closed. IVa: Dysfunction of a single body IVb:
      multiorgan dysfunction Grade V: patient death Damage or complications While complications or
      damage caused by single topical application of dexamethasone on the round window in single
      dose during surgery cochlear implant or performing in routine and systematic measurements of
      the impedances of the electrodes with the proposals and designed in the CIDC software as well
      as the procedure carried out for measuring them is estimated at zero or extremely rare
      sequences, the costs of any complications or damages related to procedures or treatments of
      the study will be funded by the Department of Otolaryngology, Hospital Italiano de Buenos
      Aires.

      Ethical considerations This protocol is drawn and carried in accordance with current national
      and international standards: Declaration of Helsinki of the World Medical Association,
      Disposition ANMAT 6770/10 and the Guidelines for Good Clinical Practice ICH E6.

      The trial protocol, the patient information and informed consent forms will be submitted to
      evaluation committee of research projects Hospital Italiano de Buenos Aires (HIBA) (CEPI) for
      possible approval.

      In all cases, the participation of the study is voluntary and certified by the process of
      informed consent.

      The right to opt be respected at all times in the studio without implying in any way any
      discrimination, differential treatment or abuse without mediate any implication in the
      treatment of the patient's disease.

      Any patient wishing leave the research protocol will be automatically removed from the
      protocol and not considered for the interpretation of results.

      Diagnostic evaluation, surgical procedure, as well as the type, make and model of implantable
      device used not differ in any way or manner to what is practiced or used routinely in our
      institution regularly.

      All data collected will be treated confidentially and anonymously. Only authorized personnel
      can access records of study according to the current legal regulation: National Personal
      Information Protection Law No. 25,326 (Law of Habeas Data).

      All patients will be informed of the study objectives; possible adverse events; the
      procedures; the potential risks they face and; the treatment allocation mechanism.
      Moreover,is the researcher's responsibility explain to patients their roles in the trial. You
      will be informed about the strict confidentiality of your personal data, but your medical
      records may be reviewed for trial purposes by authorized other than your treating physician
      individuals.

      The test results will be stored in accordance with the law of local data protection / ICH GCP
      - Guidelines and will be treated with utmost confidentiality.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

impedance


Condition

Sensorineural Hearing Loss

Intervention

Dexamethasone

Study Arms / Comparison Groups

 DEX
Description:  Topical dexamethasone will be placed at a concentration of 20mg / ml in a single dose in the tympanic cavity of the middle ear through posterior tympanotomy in the cochlear implant surgery, paying special attention to the round window membrane completely submerged in the liquid, to the insertion of the electrode assembly

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

August 9, 2017

Completion Date

November 2018

Primary Completion Date

August 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Patients who are candidates to receive a uni or bilateral cochlear implant with
             diagnosis of severe neurosensory hearing loss.

          -  Ages between 12 months and 85 years.

          -  Evaluation of internal ear anatomy performed by tomography and resonance magnetic,
             where normal cochlea and internal auditory canals are evidenced normal.

          -  Patients in which any implant of the Cochlear company is used: CI512, CI522 or CI532
             with chipset CIC4 or higher.

          -  Complete insertion of electrodes through round window, round window enlarged or
             cochleostomy, via posterior tympanotomy using the technique universally known as
             "minimally traumatic surgery"

        Exclusion Criteria:

          -  Refusal to participate in the protocol or to informed consent

          -  Intra-surgical gusher (see below, section "definitions").

          -  Contraindication to receive dexamethasone

          -  Medical, imaging, psychological or social contraindications to receive a cochlear
             implant

          -  Surgical or anesthetic contraindications for cochlear implant surgery.
      

Gender

All

Ages

12 Months - N/A

Accepts Healthy Volunteers

No

Contacts

, 541149581493, [email protected]

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT03374514

Organization ID

3233


Responsible Party

Principal Investigator

Study Sponsor

Hospital Italiano de Buenos Aires


Study Sponsor

, , 


Verification Date

December 2017