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OpenTrials
Completed

NCT Number: NCT04048239

Development of a Robotic Minimally Invasive Pathway for 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. The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • malformation or significant antecedent of mastoidectomy

Treatment and study plan

cochlear implantation

Procedure

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.

computerized tomography (CT) scan

Other

computerized tomography (CT) scan of the facial nerve

electromyograph

Other

electromyographic verification of the facial nerve

Primary outcomes

  1. cochlear implantation with the ROSA robot surgery time

    Time frame: during surgery, day 1

    cochlear implantation with the ROSA robot surgery time

  2. surgical quality based on material description and surgical technique

    Time frame: during surgery, day 1

    surgical quality based on material description and surgical technique

Secondary outcomes

  1. surgical quality based on robot precision

    Time frame: during surgery, day 1

    surgical quality based on robot precision

  2. 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

  3. surgical quality based on intraoperative electrophysiological data

    Time frame: during surgery, day 1

    surgical quality based on intraoperative electrophysiological data

  4. 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: ROSA-IC

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 7, 2019
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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