Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation

Cochlear Hearing Loss Clinical Trial

— ROSA-IC  

Official title:

Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04048239
• Other study ID #: PI2019_843_0004
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 12, 2023

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 12, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients eligible for cochlear implantation in CHU Amiens

• patient more than 18 years old.

Exclusion Criteria:

• malformation or significant antecedent of mastoidectomy

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Hearing Loss
• Hearing Loss, Sensorineural
• Implant

Intervention

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
• electromyograph
electromyographic verification of the facial nerve

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cochlear implantation with the ROSA robot surgery time	cochlear implantation with the ROSA robot surgery time	during surgery, day 1
Primary	surgical quality based on material description and surgical technique	surgical quality based on material description and surgical technique	during surgery, day 1
Secondary	surgical quality based on robot precision	surgical quality based on robot precision	during surgery, day 1
Secondary	surgical quality based on the cochlear implantation in the cochlea	surgical quality based on the cochlear implantation in the cochlea	during surgery, day 1
Secondary	surgical quality based on intraoperative electrophysiological data	surgical quality based on intraoperative electrophysiological data	during surgery, day 1
Secondary	surgical quality based on pathological complications	surgical quality based on pathological complications (facial, paralysis, infection, pain)	during surgery and postoperative period (1.5 month after surgery)