Brief Title
The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation
Official Title
The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation
Brief Summary
The cochlear implant is a neural prosthesis and has been the gold standard treatment for
severe to profound sensorineural hearing loss over several decades. The surgical procedure
for cochlear implantation aims to atraumatically insert the electrode array of the cochlear
implant into the cochlea. However, due to the location of the cochlea inside the skull, the
surgeon is required to create an access from the surface of the temporal bone to the cochlea
(inner ear). In conventional methods, this access is acquired by removal of portions of the
mastoid bone through a mastoidectomy and posterior tympanotomy. The outcome and success of
the conventional procedure varies due to mainly two factors: surgeon skill and subject
anatomical variation. To overcome these variables toward a more consistent and less invasive
cochlear implantation surgery, the development of robotic and image guided cochlear
implantation has taken place. This study primarily aims to explore the performance of robotic
cochlear implantation surgery.
Study Type
Interventional
Primary Outcome
Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures.
Secondary Outcome
Electrode array insertion outcome
Condition
Sensorineural Hearing Loss
Intervention
HEARO
Study Arms / Comparison Groups
RCI-BE-10
Description: Robot assisted cochlear implant surgery.
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
Device
Estimated Enrollment
10
Start Date
April 1, 2021
Completion Date
December 31, 2021
Primary Completion Date
December 31, 2021
Eligibility Criteria
Inclusion Criteria:
- Subjects scheduled for CI surgery according to clinical routine
- Subjects who will receive a cochlear implant
- Signed and dated informed consent form
Exclusion Criteria:
- Lack of compliance with any inclusion criteria
- Age under 18 years
- Pregnancy
- Distance of the planned trajectory to the facial nerve is < 0.4 mm as per screening CT
scan
- Distance of the planned trajectory to the chorda tympani is < 0.3 mm as per screening
CT scan
- A safe inner ear access cannot be planned for preservation of RW membrane and cochlear
structures
- Individuals where image guidance or robotic procedures are not indicated
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Marco Caversaccio, Prof. Dr., ,
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT04610450
Organization ID
RCI-NEXT
Responsible Party
Sponsor
Study Sponsor
University Hospital Inselspital, Berne
Study Sponsor
Marco Caversaccio, Prof. Dr., Principal Investigator, University Hospital Bern (Inselspital)
Verification Date
March 2021