Status not kept up to date

Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion

NCT05696171 · Nantes University Hospital · Updated 31 May 2023

What is being tested: Cochlear implant manual insertion; Cochlear implant robotized insertion
For: Profound Bilateral Hearing Loss
Kind of study: Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join: Ages 18 years and older. About 550 people. The full rules are on the registry page.
Where: France (14 sites)
When: Starts or started 2 May 2023, ends 31 May 2026. Registered 25 Jan 2023.
Results: None posted yet.

In the researchers' words

The purpose of this study is to evaluate, via a randomised controlled design, the efficacy of the robotic insertion of cochlear implant, versus manual insertion. Robotic insertion will be performed using Robotol. This is a three years interventional study involving adults with profound bilateral hearing loss. Eligible subjects will be randomized in two groups : robotic insertion, or manual insertion. Each patient will be followed during 12 months.

ClinicalTrials.gov, NCT05696171

Sites

Lille University HospitalLille, Nord, France
Bordeaux University HospitalBordeaux, France
Brest University HospitalBrest, France
Chu Clermont FerrandClermont-Ferrand, France
Hopital BicetreLe Kremlin-Bicêtre, France
AP-HMMarseille, France
CHRU de MontpellierMontpellier, France
MichelNantes, France
CHU NICENice, France
AP-HP - la Pitié-SalpétrièreParis, France
C.H.R. PontchaillouRennes, France
CHU de Saint-EtienneSaint-Etienne, France
CHRU HautepierreStrasbourg, France
CHRU de ToursTours, France