Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation

Not Applicable

Completed

• Conditions: Implant; Cochlear Hearing Loss

• Registration Number: NCT04048239
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

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.

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-07
• Study Start: 2019-10-01
• Status Verified: 2023-09
• Primary Completion: 2023-09-12
• Study Completion: 2023-09-12
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• patients eligible for cochlear implantation in CHU Amiens
• patient more than 18 years old.

Exclusion Criteria

• malformation or significant antecedent of mastoidectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
surgical quality based on material description and surgical technique	during surgery, day 1	surgical quality based on material description and surgical technique
cochlear implantation with the ROSA robot surgery time	during surgery, day 1	cochlear implantation with the ROSA robot surgery time

Secondary Outcome Measures

Name	Time	Method
surgical quality based on robot precision	during surgery, day 1	surgical quality based on robot precision
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)
surgical quality based on the cochlear implantation in the cochlea	during surgery, day 1	surgical quality based on the cochlear implantation in the cochlea

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France