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

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patient (age \> 18)

• Eligible for a cochlear implant insertion according to the HAS recommendations

• Patient having signed an informed consent

Locations
Other Locations
France
Bordeaux University Hospital
NOT_YET_RECRUITING
Bordeaux
Brest University Hospital
RECRUITING
Brest
Chu Clermont Ferrand
RECRUITING
Clermont-ferrand
Hopital Bicetre
RECRUITING
Le Kremlin-bicêtre
Lille University Hospital
RECRUITING
Lille
AP-HM
NOT_YET_RECRUITING
Marseille
CHRU de Montpellier
NOT_YET_RECRUITING
Montpellier
Michel
RECRUITING
Nantes
CHU NICE
RECRUITING
Nice
AP-HP - la Pitié-Salpétrière
NOT_YET_RECRUITING
Paris
C.H.R. Pontchaillou
NOT_YET_RECRUITING
Rennes
CHU de Saint-Etienne
RECRUITING
Saint-etienne
CHRU Hautepierre
NOT_YET_RECRUITING
Strasbourg
CHRU de Tours
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Guillaume MICHEL, PhD
guillaume.michel@chu-nantes.fr
+33.2.40.08.34.75
Backup
Cécile Dert
cecile.dert@chu-nantes.fr
+33253482852
Time Frame
Start Date: 2023-05-02
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 550
Treatments
Active_comparator: Manual insertion
Manual insertion of the cochlear implant
Experimental: Robotized insertion
Robotic insertion of the cochlear implant
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov