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Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
Sponsor: Nantes University Hospital
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
550
Start Date
2023-05-02
Completion Date
2026-05-31
Last Updated
2023-05-31
Healthy Volunteers
No
Conditions
Interventions
Cochlear implant manual insertion
Manual insertion of the cochlear implant into the round window during the surgery
Cochlear implant robotized insertion
Robotic insertion of the cochlear implant into the round window during the surgery
Locations (14)
Lille University Hospital
Lille, Nord, France
Bordeaux University Hospital
Bordeaux, France
Brest University Hospital
Brest, France
Chu Clermont Ferrand
Clermont-Ferrand, France
Hopital Bicetre
Le Kremlin-Bicêtre, France
AP-HM
Marseille, France
CHRU de Montpellier
Montpellier, France
Michel
Nantes, France
CHU NICE
Nice, France
AP-HP - la Pitié-Salpétrière
Paris, France
C.H.R. Pontchaillou
Rennes, France
CHU de Saint-Etienne
Saint-Etienne, France
CHRU Hautepierre
Strasbourg, France
CHRU de Tours
Tours, France