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 ]

The lateral distance between the center lines of the planned and actual tunnel positions at the level of the mastoid surface, and round window.


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