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

September 12, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80000
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients eligible for cochlear implantation in CHU Amiens
  • patient more than 18 years old.

Exclusion Criteria:

  • malformation or significant antecedent of mastoidectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cochlear implantation with the ROSA robot surgery time
Time Frame: during surgery, day 1
cochlear implantation with the ROSA robot surgery time
during surgery, day 1
surgical quality based on material description and surgical technique
Time Frame: during surgery, day 1
surgical quality based on material description and surgical technique
during surgery, day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical quality based on robot precision
Time Frame: during surgery, day 1
surgical quality based on robot precision
during surgery, day 1
surgical quality based on the cochlear implantation in the cochlea
Time Frame: 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
Time Frame: during surgery, day 1
surgical quality based on intraoperative electrophysiological data
during surgery, day 1
surgical quality based on pathological complications
Time Frame: during surgery and postoperative period (1.5 month after surgery)
surgical quality based on pathological complications (facial, paralysis, infection, pain)
during surgery and postoperative period (1.5 month after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

September 12, 2023

Study Completion (Actual)

September 12, 2023

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 7, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2019_843_0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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