Robotic Assisted Cochlear Implantation Feasibility Study

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Brief Title

Robotic Assisted Cochlear Implantation Feasibility Study

Official Title

Robotic Assisted Cochlear Implantation Feasibility Study

Brief Summary

      A first in man clinical trial to asses the the use of am image guided robotic system to
      safely and effectively create a minimally invasive access tunnel to the middle ear cavity to
      allow access to the round window for cochlear implant electrode insertion.
    

Detailed Description

      A first in man feasibility study of an image guided robotic system for performing a key-hole
      approach to the middle ear cavity.
    


Study Type

Interventional


Primary Outcome

Drilling accuracy

Secondary Outcome

 Number of successfully completed robotic procedures

Condition

Sensory Hearing Loss

Intervention

Minimally invasive robotic cochlear implantation

Study Arms / Comparison Groups

 Experimental
Description:  Minimally invasive robotic cochlear implantation with custom device

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

9

Start Date

July 1, 2016

Completion Date

August 22, 2018

Primary Completion Date

August 22, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Geographically and physically able to attend scheduled evaluations and follow-up
             appointments

          -  Indicated for cochlear implantation

          -  Age 18 years or older

          -  Fluent in German or French

          -  Sufficient facial recess size ( > 2.5 mm between the facial nerve and chorda tympani)

        Exclusion Criteria:

          -  Pregnancy

          -  Anatomical malformation of the middle or inner ear or unusual facial nerve course

          -  Lack of compliance with any inclusion criteria
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Marco Caversaccio, MD, , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT02641795

Organization ID

CIV-13-12-011779

Secondary IDs

PB_2017-0031

Responsible Party

Sponsor

Study Sponsor

University Hospital Inselspital, Berne

Collaborators

 University of Bern

Study Sponsor

Marco Caversaccio, MD, Principal Investigator, University Hospital Inselspital, Bern


Verification Date

October 2018