Clinical Trial: Robotic Assisted Cochlear Implantation Feasibility Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Summary:
Sponsor: University Hospital Inselspital, Berne
Current Primary Outcome: Drilling accuracy [ Time Frame: The procedure ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Successful access to the round window [ Time Frame: The procedure ]Visibility of round window through the drilled tunnel determined on endoscopic images
- Success of electrode insertion [ Time Frame: During the procedure ]Insertion depth and scala determined from postop CT
- Registration accuracy [ Time Frame: The procedure ]Fiducial matching error of patient to image registration
- Facial nerve function [ Time Frame: Within two weeks after the procedure ]Postoperative facial nerve function on electromyography as compared to preoperative baseline measurements
- Distances between the drilled tunnel and the surrounding structures of interest [ Time Frame: The procedure ]Distances as measured between segmented structures from postoperative CT images
- Procedure duration [ Time Frame: During the procedure ]Time it takes to complete the medical procedure
- Chorda tympani function [ Time Frame: Within two weeks after the procedure ]Postoperative sensory analysis of taste as compared to preoperative measures
- clinical complications [ Time Frame: Within two weeks after the procedure ]
- Invasiveness of the intervention [ Time Frame: The procedure ]Size of incision made for the drill tunnel
- Invasiveness of screw implantation [ Time Frame: The procedure ]Size of incisions made for implanted screws
Original Secondary Outcome: Same as current
Information By: University Hospital Inselspital, Berne
Dates:
Date Received: December 19, 2015
Date Started: July 2014
Date Completion:
Last Updated: January 24, 2017
Last Verified: January 2017