NCT04048239

Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cochlear Hearing Loss
• Implant

Interventions

Type	Name	Description
PROCEDURE	cochlear implantation	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.
OTHER	computerized tomography (CT) scan	computerized tomography (CT) scan of the facial nerve
OTHER	electromyograph	electromyographic verification of the facial nerve

Timeline

• Start date: 2019-10-01
• Primary completion: 2023-09-12
• Completion: 2023-09-12
• First posted: 2019-08-07
• Last updated: 2025-09-19

Locations

1 site across 1 country: France