Clinical trial NCT05696171: Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
Official title: Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Profound Bilateral Hearing Loss
Keywords: Profound hearing loss, cochlear implant, RobOtol®
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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®)

Primary outcomes:
measure: Speech discrimination score
timeFrame: 1 year
Secondary outcomes:
measure: Speech discrimination score
timeFrame: Baseline, 6 months
measure: Speech Reception Threshold (SRT 50)
timeFrame: 6 months, 12 months
measure: Speech audiometry in noise
timeFrame: 6 months, 12 months
measure: Rate of incomplete insertion
timeFrame: Day one post operative
measure: Rate of electrode translocations
timeFrame: Day one post operative
measure: Residual hearing
timeFrame: Baseline, 6 months, 12 months
measure: Pure-tone audiometry
timeFrame: 6 months, 12 months
measure: Complications related to the implant
timeFrame: Day one, 1 month, 3 months, 6 months, 12 months
measure: Quality of life of patients with HUI3
timeFrame: Baseline, one month, 3 months, 6 months, 12 months
measure: Quality of life of patients with EQ-5D
timeFrame: Baseline, one month, 3 months, 6 months, 12 months
measure: Vestibular function with VHIT
timeFrame: Baseline, 12 months
measure: Vestibular function with Caloric test results
timeFrame: Baseline, 12 months
measure: Vestibular function with MVEP
timeFrame: Baseline, 12 months
measure: Incremental cost-effectiveness ratio (cost per point of speech discrimination score gain) from a collective perspective
timeFrame: 12 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University Hospital
state: Nord
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
city: Le Kremlin-Bicêtre
country: France
facility: Hopital Bicetre
city: Marseille
country: France
facility: AP-HM
city: Montpellier
country: France
facility: CHRU de Montpellier
city: Nantes
country: France
facility: Michel
city: Nice
country: France
facility: CHU NICE
city: Paris
country: France
facility: AP-HP - la Pitié-Salpétrière
city: Rennes
country: France
facility: C.H.R. Pontchaillou
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
city: Strasbourg
country: France
facility: CHRU Hautepierre
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: Nantes University Hospital
name: Guillaume MICHEL
role: PRINCIPAL_INVESTIGATOR
References: