Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion (ROBIICCA)

The purpose of this study is to evaluate, via a randomised controlled design, the efficacy of the robotic insertion of cochlear implant, versus manual insertion. Robotic insertion will be performed using Robotol.

This is a three years interventional study involving adults with profound bilateral hearing loss.

Eligible subjects will be randomized in two groups : robotic insertion, or manual insertion. Each patient will be followed during 12 months.

Study Overview

• Status: Recruiting
• Conditions: Profound Bilateral Hearing Loss
• Intervention / Treatment: Procedure: Cochlear implant manual insertion; Procedure: Cochlear implant robotized insertion

Detailed Description

Cochlear implants are currently the only option for the rehabilitation of bilateral profound hearing loss. Cochlear implant surgery efficacy has been largely demonstrated by numerous studies. But, despite multiple contributors, accuracy and sensitivity of cochlear implant insertion constitute the major and the single factor that surgeons have under control.

This manual surgery is performed in an extremely constrained environment and must be as much as delicate as possible to preserve patient's residual hearing potential. Manual insertion is still largely subject to experience and dexterity of the surgeon. Factors associated with the surgical insertion (such as incomplete or traumatic insertions, translocations, destruction of residual hearing) have a negative impact on final hearing correction performance.

To optimise the hearing results, the insertion must be precise, linear and atraumatic. These conditions may be achieved by robotic insertion.

The RobOtol® is an innovative robotic assistance system dedicated to ear surgery, designed and built in France. This is a compact serial robot with 7 degrees of freedom and high resolution, allowing lower insertion forces and higher insertion depth than the manual approach. Pilot clinical studies have already reported a reduced frequency of translocations via robotic assistance and a reduction in cochlear trauma.

The objective of Robiicca is to evaluate, via a randomised controlled design, the efficacy at 1 year of this robotic technology in cochlear implantation in adults.The hypothesis is that the optimization of the surgical procedure with the RobOtol® will maximize the audiometric results, as well as the residual hearing and the vestibular function.

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume MICHEL, PhD; Phone Number: +33.2.40.08.34.75; Email: guillaume.michel@chu-nantes.fr
• Study Contact Backup: Name: Cécile Dert; Phone Number: +33253482852; Email: cecile.dert@chu-nantes.fr

Study Locations

• France
  • Bordeaux, France, 33604
    • Not yet recruiting
    • Bordeaux University Hospital
    • Contact: Damien BONNARD
    • Principal Investigator: Damien BONNARD, Pr
  • Brest, France
    • Recruiting
    • Brest University Hospital
    • Contact: Rémi MARIANOWSKI, MD, PhD
    • Principal Investigator: Rémi MARIANOWSKI
  • Clermont-Ferrand, France
    • Recruiting
    • Chu Clermont Ferrand
    • Contact: Thierry MOM
    • Principal Investigator: Thierry MOM, Pr
  • Le Kremlin-Bicêtre, France, 94270
    • Recruiting
    • Hôpital Bicêtre
    • Contact: Jérôme NEVOUX
    • Principal Investigator: Jérôme NEVOUX
  • Marseille, France
    • Not yet recruiting
    • AP-HM
    • Contact: Stephane Roman
    • Principal Investigator: Stephane Roman
  • Montpellier, France
    • Not yet recruiting
    • CHRU de Montpellier
    • Contact: Frédéric Venail
    • Principal Investigator: Frédéric VENAIL
  • Nantes, France
    • Recruiting
    • Michel
    • Contact: Guillaume MICHEL, MD; Email: guillaume.michel@chu-nantes.fr
  • Nice, France
    • Recruiting
    • CHU Nice
    • Contact: Nicolas GUEVARA
    • Principal Investigator: Nicolas GUEVARA
  • Paris, France
    • Not yet recruiting
    • AP-HP - la Pitié-Salpétrière
    • Contact: Yann NGUYEN, Profesor
    • Principal Investigator: Yann NGUYEN
  • Rennes, France, 35033
    • Not yet recruiting
    • C.H.R. Pontchaillou
    • Contact: Benoit GODEY, MD
    • Principal Investigator: Benoit GODEY
  • Saint-Etienne, France, 42270
    • Recruiting
    • Chu de Saint-Etienne
    • Contact: Alexandre KARKAS
    • Principal Investigator: Alexandre KARKAS
  • Strasbourg, France, 67098
    • Not yet recruiting
    • CHRU Hautepierre
    • Contact: Anne Charpiot
    • Principal Investigator: anne Charpiot, MD
  • Tours, France, 37000
    • Not yet recruiting
    • CHRU de Tours
    • Contact: David BAKHOS
    • Principal Investigator: David BAKHOS
  • Nord
    • Lille, Nord, France, 59000
      • Recruiting
      • Lille University Hospital
      • Contact: Michael RISOUD
      • Principal Investigator: Michael RISOUD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patient (age > 18)
• Eligible for a cochlear implant insertion according to the HAS recommendations
• Patient having signed an informed consent

Exclusion Criteria:

Exclusion Criteria:

• Profound hearing loss linked to meningitis
• Bilateral cochlear implants insertion during the same surgery
• Removal and re-insertion of a cochlear implant (due to a failure for example)
• Patient under guardianship or curatorship
• Contraindication to the use of the RobOtol®:

Patients wearing electronic devices directly connected to the brain or nervous system.

Presence of medical conditions that prohibit general anesthesia. Impossibility of viewing the anatomy adequately. Any situation that, in the doctor's opinion, might involve risk for the patient

• Anticipated difficulty to comply with the investigation (job transfer, geographical distance, lack of motivation, incapacity to fulfill the questionnaires),
• Patient previously included in Robiicca study (for the opposite site)
• Perimodiolar implants (not compatible with the RobOtol®)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual insertion; Manual insertion of the cochlear implant	Procedure: Cochlear implant manual insertion; Manual insertion of the cochlear implant into the round window during the surgery
Experimental: Robotized insertion; Robotic insertion of the cochlear implant	Procedure: Cochlear implant robotized insertion; Robotic insertion of the cochlear implant into the round window during the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech discrimination score	the speech discrimination score is the percentage of repeated words in silence, with a monosyllabic list, at 60dB, cochlear implant activated.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech discrimination score	Speech discrimination score (percent of words recognized in monosyllabic list) at 60 dB	Baseline, 6 months
Speech Reception Threshold (SRT 50)	The speech recognition threshold (SRT) examines at which level 50% of the speech material (usually numbers or spondaic words) is repeated correctly. In addition, SRT gives an index of the hearing sensitivity of speech and helps determine the starting point for other supra-threshold measures such as WR (Word Recognition).	6 months, 12 months
Speech audiometry in noise	Signal to Noise Ratio to achieve 50% or 80% intelligibility (SNR50 and SNR80) with the Fra-Matrix noise test	6 months, 12 months
Rate of incomplete insertion	Number of electrodes inserted at immediate post-operative imaging by Cone Beam or CT scan.	Day one post operative
Rate of electrode translocations	Analysis of translocations using software measures after Cone beam or CT scan (blinded centralized analysis)	Day one post operative
Residual hearing	Pure Tone Audiometry thresholds, implant deactivated, at 250, 500, 1000, 2000 and 4000 Hz (mean of the 5 frequencies)	Baseline, 6 months, 12 months
Pure-tone audiometry	Pure Tone Audiometry thresholds, implant activated, at 250, 500, 1000, 2000 and 4000 Hz (mean of the 5 frequencies)	6 months, 12 months
Complications related to the implant	Complications related to implant surgery (peripheral facial palsy, cerebrospinal fluid leaks, neurovegetative disorders, major bleeding, neurological complications, infections, scars disorders, pain, hematoma, dizziness, tinnitus, tympanic perforations, and implant-linked complications : breakdowns, electrode displacements, magnet displacement, implant body displacement, electrode misplaced)	Day one, 1 month, 3 months, 6 months, 12 months
Quality of life of patients with HUI3	HUI-3 classification system consists of 8 attributes including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. These attributes range from five or six levels of health states for each attribute.	Baseline, one month, 3 months, 6 months, 12 months
Quality of life of patients with EQ-5D	EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition.	Baseline, one month, 3 months, 6 months, 12 months
Vestibular function with VHIT	Video head impulse test (vHIT) allows to identify the overt and covert saccades and studies the gain of vestibulo-ocular reflex (VOR) of each semicircular canal.	Baseline, 12 months
Vestibular function with Caloric test results	The caloric test uses a nonphysiologic stimulus to induce endolymphatic flow in the horizontal semicircular canal and horizontal nystagmus by creating a temperature gradient from one side of the canal to the other.	Baseline, 12 months
Vestibular function with MVEP	Myogenic Vestibular Evoked Potential (MVEP) detects the presence of reproductible waveforms of normal morphology in latency and amplitude	Baseline, 12 months
Incremental cost-effectiveness ratio (cost per point of speech discrimination score gain) from a collective perspective	Effectiveness criteria will be the speech discrimination score (number of words recognized in monosyllabic list) at 60 dB at M12. Costs will be estimated in 3 steps: 1) direct costs related to treatment (DRG, length of stay) and one month outpatient resources consumption after surgery; 2) monetary valuation of resources consumed (using NHI official tariffs, and data from the French National Hospitals' Cost Study); 3) cost calculation by multiplying quantities of resources with their corresponding units costs.	12 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Guillaume MICHEL, CHU de Nantes

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Profound hearing loss, cochlear implant, RobOtol®
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Bilateral
• Other Study ID Numbers: RC22_0384

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No