Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compare… (NCT05696171) | Clinical Trial Compass
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Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
France550 participantsStarted 2023-05-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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®)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.