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ClinicalTrials.gov ID

NCT05696171

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

550Estimated

Last Update Posted

May 31, 2023Actual

Start Date

May 2, 2023Actual

Primary Completion Date

May 31, 2026Estimated

Completion Date

May 31, 2026Estimated

Official Title

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

Brief 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.

Detailed Description

Cochlear implants are currently the only option for the rehabilitation of bilateral profound hearing loss. Cochlear implant surgery efficacy has been largely demonstrated by numerous studies. But, despite multiple contributors, accuracy and sensitivity of cochlear implant insertion constitute the major and the single factor that surgeons have under control.

This manual surgery is performed in an extremely constrained environment and must be as much as delicate as possible to preserve patient's residual hearing potential. Manual insertion is still largely subject to experience and dexterity of the surgeon. Factors associated with the surgical insertion (such as incomplete or traumatic insertions, translocations, destruction of residual hearing) have a negative impact on final hearing correction performance.

To optimise the hearing results, the insertion must be precise, linear and atraumatic. These conditions may be achieved by robotic insertion.

The RobOtol® is an innovative robotic assistance system dedicated to ear surgery, designed and built in France. This is a compact serial robot with 7 degrees of freedom and high resolution, allowing lower insertion forces and higher insertion depth than the manual approach. Pilot clinical studies have already reported a reduced frequency of translocations via robotic assistance and a reduction in cochlear trauma.

The objective of Robiicca is to evaluate, via a randomised controlled design, the efficacy at 1 year of this robotic technology in cochlear implantation in adults.The hypothesis is that the optimization of the surgical procedure with the RobOtol® will maximize the audiometric results, as well as the residual hearing and the vestibular function.

• Profound Bilateral Hearing Loss

• Cochlear implant manual insertion
• Cochlear implant robotized insertion

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Exclusion Criteria:

• 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®)

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Nantes University HospitalOTHER

guillaume.michel@chu-nantes.fr