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RecruitingNot ApplicableNCT05696171

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

Sponsor

Nantes University Hospital

Enrollment

550 participants

Start Date

May 2, 2023

Study Type

INTERVENTIONAL

Conditions

Profound Bilateral Hearing Loss

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

Min Age: 18 Years

Inclusion Criteria3

  • Adult patient (age > 18)
  • Eligible for a cochlear implant insertion according to the HAS recommendations
  • Patient having signed an informed consent

Exclusion Criteria10

  • Profound hearing loss linked to meningitis
  • Bilateral cochlear implants insertion during the same surgery
  • Removal and re-insertion of a cochlear implant (due to a failure for example)
  • Patient under guardianship or curatorship
  • Contraindication to the use of the RobOtol®:
  • Patients wearing electronic devices directly connected to the brain or nervous system.
  • Presence of medical conditions that prohibit general anesthesia. Impossibility of viewing the anatomy adequately. Any situation that, in the doctor's opinion, might involve risk for the patient
  • Anticipated difficulty to comply with the investigation (job transfer, geographical distance, lack of motivation, incapacity to fulfill the questionnaires),
  • Patient previously included in Robiicca study (for the opposite site)
  • Perimodiolar implants (not compatible with the RobOtol®)

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Interventions

PROCEDURECochlear implant manual insertion

Manual insertion of the cochlear implant into the round window during the surgery

PROCEDURECochlear 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

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NCT05696171