Robotic Assisted Cochlear Implantation Feasibility Study

NCT02641795 | Terminated DMC

• 3 other identifiers: CIV-13-12-011779PB_2017-00312013-MD-0042
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensory Hearing Loss

Keywords

cochlear implantation; robotics; image guidance

Outcome Measures

Primary Outcomes (1)

• Drilling accuracy

  The lateral distance between the center lines of the planned and drilled tunnel positions at the level of the facial nerve measured from medical image data

  Image data acquired during the procedure

Secondary Outcomes (8)

• Number of successfully completed robotic procedures

  The procedure (day 0)

• The number of successful cochlear implant electrode array insertions

  The procedure (day 0)

• Registration accuracy

  The procedure (day 0)

• Time of the robotic procedure and its subparts

  The procedure (day 0)

• Adverse events

  day 0-30

Study Arms (1)

Experimental

EXPERIMENTAL

Minimally invasive robotic cochlear implantation with custom device

Device: Minimally invasive robotic cochlear implantation

Interventions

Minimally invasive robotic cochlear implantation DEVICE

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Inselspital University Hospital Bern

Bern, 3008, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Caversaccio, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2015
• First Posted: December 29, 2015
• Study Start: July 1, 2016
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

CH (1)