| Registry | NCT04048239, acronym ROSA-IC |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, treatment |
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| Enrollment | 9 (Actual) |
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| Sponsor | Centre Hospitalier Universitaire, Amiens (Other) |
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| Conditions | Cochlear Hearing Loss, Implant |
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| Interventions | cochlear implantation, computerized tomography (CT) scan, electromyograph (Procedure, other) |
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| Dates | start 2019-10-01, primary completion 2023-09-12, completion 2023-09-12, first posted 2019-08-07, last updated 2025-09-19 |
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| Locations | 1 site in France |
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Related Papers Related Patents Related Grants Related Experts
All trials for Cochlear Hearing Loss All trials for Implant All trials of cochlear implantation All trials of computerized tomography (CT) scan
-Summary
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.
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+Detailed description
The ROSA robot coupled to the O-Arm scanner will guide the milling to the round window, whose path has been previously modeled, with the identification of the facial nerve. Milling will be done in 2 stages with a CT (computerised tomography scan) and electromyographic verification of the facial nerve. The insertion of the implant will be performed manually under endoscopic control. The preoperative and postoperative course of the patient will be identical.
+Arms and interventions
- cochlear implantation (Procedure): 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.
- computerized tomography (CT) scan (Other): computerized tomography (CT) scan of the facial nerve
- electromyograph (Other): electromyographic verification of the facial nerve
+Outcome measures
Primary outcomes
- cochlear implantation with the ROSA robot surgery time [during surgery, day 1]: cochlear implantation with the ROSA robot surgery time
- surgical quality based on material description and surgical technique [during surgery, day 1]: surgical quality based on material description and surgical technique
Secondary outcomes
- surgical quality based on robot precision [during surgery, day 1]: surgical quality based on robot precision
- surgical quality based on the cochlear implantation in the cochlea [during surgery, day 1]: surgical quality based on the cochlear implantation in the cochlea
- surgical quality based on intraoperative electrophysiological data [during surgery, day 1]: surgical quality based on intraoperative electrophysiological data
- surgical quality based on pathological complications [during surgery and postoperative period (1.5 month after surgery)]: surgical quality based on pathological complications (facial, paralysis, infection, pain)
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* patients eligible for cochlear implantation in CHU Amiens
* patient more than 18 years old.
Exclusion Criteria:
* malformation or significant antecedent of mastoidectomy
+Locations (1)
| Facility | City | Country | Status |
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| CHU Amiens | Amiens | France | |
+Publications
- Results publication: Klopp-Dutote N, Lefranc M, Strunski V, Page C. Minimally invasive fully ROBOT-assisted cochlear implantation in humans: Preliminary results in five consecutive patients. Clin Otolaryngol. 2021 Nov;46(6):1326-1330. doi: 10.1111/coa.13840. Epub 2021 Aug 17. No abstract available. PMID 34310841
+Investigators
- Nathalie klopp-Dutote, MD, Principal investigator, CHU amiens