Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation

Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Source 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.

Overall Status Recruiting
Start Date October 1, 2019
Completion Date October 2020
Primary Completion Date August 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
cochlear implantation with the ROSA robot surgery time during surgery, day 1
surgical quality based on material description and surgical technique during surgery, day 1
Secondary Outcome
Measure Time Frame
surgical quality based on robot precision during surgery, day 1
surgical quality based on the cochlear implantation in the cochlea during surgery, day 1
surgical quality based on intraoperative electrophysiological data during surgery, day 1
surgical quality based on pathological complications during surgery and postoperative period (1.5 month after surgery)
Enrollment 10
Condition
Intervention

Intervention Type: Procedure

Intervention Name: cochlear implantation

Description: 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.

Intervention Type: Other

Intervention Name: computerized tomography (CT) scan

Description: computerized tomography (CT) scan of the facial nerve

Intervention Type: Other

Intervention Name: electromyograph

Description: electromyographic verification of the facial nerve

Eligibility

Criteria:

Inclusion Criteria:

- patients eligible for cochlear implantation in CHU Amiens

- patient more than 18 years old.

Exclusion Criteria:

- malformation or significant antecedent of mastoidectomy

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Nathalie klopp-Dutote, MD Principal Investigator CHU amiens
Overall Contact

Last Name: Nathalie klopp-Dutote, MD

Phone: (33)322088960

Phone Ext.: 37110

Email: [email protected]

Location
Facility: Status: CHU Amiens
Location Countries

France

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym ROSA-IC
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov