Evaluating robotic versus manual cochlear implant insertion for hearing loss
Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
This study is testing if using a robot to insert cochlear implants can help adults with severe hearing loss have better results and fewer problems compared to the traditional manual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 14 sites (Lille, Nord and 13 other locations) |
| Trial ID | NCT05696171 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy of robotic cochlear implant insertion using the RobOtol® system against traditional manual insertion in adults with profound bilateral hearing loss. Participants will be randomly assigned to one of two groups: robotic or manual insertion, and will be followed for 12 months post-surgery. The study seeks to determine if robotic assistance can improve surgical accuracy and reduce complications associated with manual insertion. The RobOtol® system is designed to enhance precision and minimize trauma during the insertion process.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are eligible for cochlear implant surgery according to established guidelines.
Not a fit: Patients with profound hearing loss due to meningitis or those requiring simultaneous bilateral cochlear implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved hearing outcomes and reduced surgical complications for patients receiving cochlear implants.
How similar studies have performed: Previous pilot studies have shown promising results with robotic assistance in cochlear implant surgeries, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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®)
Where this trial is running
Lille, Nord and 13 other locations
- Lille University Hospital — Lille, Nord, France (Recruiting)
- Bordeaux University Hospital — Bordeaux, France (Not_yet_recruiting)
- Brest University Hospital — Brest, France (Recruiting)
- Chu Clermont Ferrand — Clermont-Ferrand, France (Recruiting)
- Hopital Bicetre — Le Kremlin-Bicêtre, France (Recruiting)
- Ap-Hm — Marseille, France (Not_yet_recruiting)
- CHRU de Montpellier — Montpellier, France (Not_yet_recruiting)
- Michel — Nantes, France (Recruiting)
- Chu Nice — Nice, France (Recruiting)
- AP-HP - la Pitié-Salpétrière — Paris, France (Not_yet_recruiting)
- C.H.R. Pontchaillou — Rennes, France (Not_yet_recruiting)
- CHU de Saint-Etienne — Saint-Etienne, France (Recruiting)
- CHRU Hautepierre — Strasbourg, France (Not_yet_recruiting)
- CHRU de Tours — Tours, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Guillaume MICHEL — Nantes University Hospital
- Study coordinator: Guillaume MICHEL, PhD
- Email: guillaume.michel@chu-nantes.fr
- Phone: +33.2.40.08.34.75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.