Robotic Assisted Cochlear Implantation Feasibility Study

Not Applicable

Terminated

• Conditions: Sensory Hearing Loss
• Interventions: Device: Minimally invasive robotic cochlear implantation

• Registration Number: NCT02641795
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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 Timeline

• Study First Submitted: 2015-12-19
• Study First Submitted QC: 2015-12-23
• Study First Posted: 2015-12-29
• Study Start: 2016-07-01
• Primary Completion: 2018-08-22
• Study Completion: 2018-08-22
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Minimally invasive robotic cochlear implantation	Minimally invasive robotic cochlear implantation with custom device

Primary Outcome Measures

Name	Time	Method
Drilling accuracy	Image data acquired during the procedure	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

Secondary Outcome Measures

Name	Time	Method
Invasiveness of the intervention	The procedure (day 0)	Size of incision (mm)
Number of successfully completed robotic procedures	The procedure (day 0)	The number of procedures drilled robotically to the middle ear cavity
Registration accuracy	The procedure (day 0)	Fiducial matching error of patient to image registration
Time of the robotic procedure and its subparts	The procedure (day 0)	Total time of the robotic procedure from opening to closing (mean and standard deviation) and of the subprocesses
Adverse events	day 0-30	Any clinical complications including facial nerve or chorda tympani damage, infection, negative audiological outcomes etc
Blood loss	The procedure (day 0)	Intraoperative blood loss (ml)
The number of successful cochlear implant electrode array insertions	The procedure (day 0)	Number of electrode arrays implanted through the key-hole approach to the middle ear cavity
Postoperative pain	day 0-30	Pain scale and prescribed pain medication

Trial Locations

Locations (1)

Inselspital University Hospital Bern; 🇨🇭 Bern, Switzerland