Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure

NCT04777565 | Completed

• 1 other identifier: MED-EL_HEARO_french_study
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.

Conditions

Sensorineural Hearing Loss, Bilateral

Keywords

cochlear implant; robotic surgery; electrode insertion

Outcome Measures

Primary Outcomes (1)

• Electrode array insertion

  • Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures (i.e. proportion of successful insertions with the procedure out of the total number of patients included in the study).

  During surgery

Secondary Outcomes (10)

• Electrode array insertion outcome (efficacy)

  During surgery

• Electrode array insertion outcome (efficacy)

  During surgery

• Electrode array insertion outcome (efficacy)

  During surgery

• Electrode array insertion outcome (efficacy)

  During surgery

• Insertion depth prediction accuracy (efficacy)

  During surgery

Study Arms (1)

CI surgery

EXPERIMENTAL

cochlear implant surgery

Other: Robotic surgery

Interventions

Robotic surgery OTHER

Cochlear implant surgery with HEARO procedure

CI surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects scheduled for CI surgery according to clinical routine
• Subjects who will receive a cochlear implant of the MED-EL portfolio
• Signed and dated informed consent form

You may not qualify if:

• Age under 18 years
• Pregnancy
• Distance of the planned trajectory to the facial nerve is \< 0.4 mm as per screening CT scan
• Distance of the planned trajectory to the chorda tympani is \< 0.3 mm as per screening CT scan
• A safe inner ear access cannot be planned for preservation of RW membrane and cochlear structures
• Individuals where image guidance or robotic procedures are not indicated
• Individuals who have known allergy to components of the cochlear implant

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

• Fourez AL, Kaderbay A, Villerabel C, Korchagina J, Pean V, Mondain M, Venail F. Implementation of Robot-Assisted Minimally Invasive Cochlear Implantation: A Feasibility Study. Otol Neurotol. 2025 Aug 1;46(7):809-815. doi: 10.1097/MAO.0000000000004531. Epub 2025 May 23.

  PMID: 40423721 DERIVED

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Frédéric Venail, Pr

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: March 2, 2021
• Study Start: September 15, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)