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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT04048239
Collaborator
(none)
10
Enrollment
1
Location
24
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: cochlear implantation
  • Other: computerized tomography (CT) scan
  • Other: electromyograph
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation
Actual Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Outcome Measures

Primary Outcome Measures

  1. cochlear implantation with the ROSA robot surgery time [during surgery, day 1]

    cochlear implantation with the ROSA robot surgery time

  2. surgical quality based on material description and surgical technique [during surgery, day 1]

    surgical quality based on material description and surgical technique

Secondary Outcome Measures

  1. surgical quality based on robot precision [during surgery, day 1]

    surgical quality based on robot precision

  2. surgical quality based on the cochlear implantation in the cochlea [during surgery, day 1]

    surgical quality based on the cochlear implantation in the cochlea

  3. surgical quality based on intraoperative electrophysiological data [during surgery, day 1]

    surgical quality based on intraoperative electrophysiological data

  4. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • patients eligible for cochlear implantation in CHU Amiens

  • patient more than 18 years old.

Exclusion Criteria:
  • malformation or significant antecedent of mastoidectomy

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Amiens France 80000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Nathalie klopp-Dutote, MD, CHU amiens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT04048239
Other Study ID Numbers:
  • PI2019_843_0004
First Posted:
Aug 7, 2019
Last Update Posted:
Dec 7, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
cochlear implant
robotic
mini-invasive
Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sensorineural

Study Results

No Results Posted as of Dec 7, 2020