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

Primary Purpose

Cochlear Hearing Loss, Implant

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cochlear implantation
computerized tomography (CT) scan
electromyograph
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cochlear Hearing Loss focused on measuring cochlear implant, robotic, mini-invasive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Amiens

Outcomes

Primary Outcome Measures

cochlear implantation with the ROSA robot surgery time
cochlear implantation with the ROSA robot surgery time
surgical quality based on material description and surgical technique
surgical quality based on material description and surgical technique

Secondary Outcome Measures

surgical quality based on robot precision
surgical quality based on robot precision
surgical quality based on the cochlear implantation in the cochlea
surgical quality based on the cochlear implantation in the cochlea
surgical quality based on intraoperative electrophysiological data
surgical quality based on intraoperative electrophysiological data
surgical quality based on pathological complications
surgical quality based on pathological complications (facial, paralysis, infection, pain)

Full Information

First Posted
August 6, 2019
Last Updated
September 12, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT04048239
Brief Title
Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation
Acronym
ROSA-IC
Official Title
Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 12, 2023 (Actual)
Study Completion Date
September 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cochlear Hearing Loss, Implant
Keywords
cochlear implant, robotic, mini-invasive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
cochlear implantation
Intervention 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(s)
computerized tomography (CT) scan
Intervention Description
computerized tomography (CT) scan of the facial nerve
Intervention Type
Other
Intervention Name(s)
electromyograph
Intervention Description
electromyographic verification of the facial nerve
Primary Outcome Measure Information:
Title
cochlear implantation with the ROSA robot surgery time
Description
cochlear implantation with the ROSA robot surgery time
Time Frame
during surgery, day 1
Title
surgical quality based on material description and surgical technique
Description
surgical quality based on material description and surgical technique
Time Frame
during surgery, day 1
Secondary Outcome Measure Information:
Title
surgical quality based on robot precision
Description
surgical quality based on robot precision
Time Frame
during surgery, day 1
Title
surgical quality based on the cochlear implantation in the cochlea
Description
surgical quality based on the cochlear implantation in the cochlea
Time Frame
during surgery, day 1
Title
surgical quality based on intraoperative electrophysiological data
Description
surgical quality based on intraoperative electrophysiological data
Time Frame
during surgery, day 1
Title
surgical quality based on pathological complications
Description
surgical quality based on pathological complications (facial, paralysis, infection, pain)
Time Frame
during surgery and postoperative period (1.5 month after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie klopp-Dutote, MD
Organizational Affiliation
CHU amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation

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