Cochlear Hearing Loss Clinical Trial
— ROSA-ICOfficial title:
Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation
Verified date | September 2023 |
Source | Centre Hospitalier Universitaire, Amiens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cochlear Implantation is a system developed to restore hearing in people with profound sensorineural hearing loss, whose classical hearing aids are ineffective. Surgery is necessary to insert the internal part into the cochlea and requires milling the mastoid to access the round window. This approach is technically difficult, and is performed under a microscope by an experienced surgeon. The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics.
Status | Completed |
Enrollment | 9 |
Est. completion date | September 12, 2023 |
Est. primary completion date | September 12, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients eligible for cochlear implantation in CHU Amiens - patient more than 18 years old. Exclusion Criteria: - malformation or significant antecedent of mastoidectomy |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cochlear implantation with the ROSA robot surgery time | cochlear implantation with the ROSA robot surgery time | during surgery, day 1 | |
Primary | surgical quality based on material description and surgical technique | surgical quality based on material description and surgical technique | during surgery, day 1 | |
Secondary | surgical quality based on robot precision | surgical quality based on robot precision | during surgery, day 1 | |
Secondary | surgical quality based on the cochlear implantation in the cochlea | surgical quality based on the cochlear implantation in the cochlea | during surgery, day 1 | |
Secondary | surgical quality based on intraoperative electrophysiological data | surgical quality based on intraoperative electrophysiological data | during surgery, day 1 | |
Secondary | surgical quality based on pathological complications | surgical quality based on pathological complications (facial, paralysis, infection, pain) | during surgery and postoperative period (1.5 month after surgery) |
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