Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation (ROSA-IC)

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Implant; Cochlear Hearing Loss

Treatments: Procedure: cochlear implantation; Other: electromyograph; Other: computerized tomography (CT) scan

Study type: Interventional

Funder types: Other

Identifiers

NCT04048239

PI2019_843_0004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• malformation or significant antecedent of mastoidectomy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)