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

Primary Purpose

Profound Bilateral Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cochlear implant manual insertion
Cochlear implant robotized insertion
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Profound Bilateral Hearing Loss focused on measuring Profound hearing loss, cochlear implant, RobOtol®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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®)

Sites / Locations

  • Lille University HospitalRecruiting
  • Bordeaux University Hospital
  • Brest University HospitalRecruiting
  • Chu Clermont FerrandRecruiting
  • Hopital BicetreRecruiting
  • AP-HM
  • CHRU de Montpellier
  • MichelRecruiting
  • CHU NICERecruiting
  • AP-HP - la Pitié-Salpétrière
  • C.H.R. Pontchaillou
  • CHU de Saint-EtienneRecruiting
  • CHRU Hautepierre
  • CHRU de Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Manual insertion

Robotized insertion

Arm Description

Manual insertion of the cochlear implant

Robotic insertion of the cochlear implant

Outcomes

Primary Outcome Measures

Speech discrimination score
the speech discrimination score is the percentage of repeated words in silence, with a monosyllabic list, at 60dB, cochlear implant activated.

Secondary Outcome Measures

Speech discrimination score
Speech discrimination score (percent of words recognized in monosyllabic list) at 60 dB
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).
Speech audiometry in noise
Signal to Noise Ratio to achieve 50% or 80% intelligibility (SNR50 and SNR80) with the Fra-Matrix noise test
Rate of incomplete insertion
Number of electrodes inserted at immediate post-operative imaging by Cone Beam or CT scan.
Rate of electrode translocations
Analysis of translocations using software measures after Cone beam or CT scan (blinded centralized analysis)
Residual hearing
Pure Tone Audiometry thresholds, implant deactivated, at 250, 500, 1000, 2000 and 4000 Hz (mean of the 5 frequencies)
Pure-tone audiometry
Pure Tone Audiometry thresholds, implant activated, at 250, 500, 1000, 2000 and 4000 Hz (mean of the 5 frequencies)
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)
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.
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.
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.
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.
Vestibular function with MVEP
Myogenic Vestibular Evoked Potential (MVEP) detects the presence of reproductible waveforms of normal morphology in latency and amplitude
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.

Full Information

First Posted
January 13, 2023
Last Updated
May 30, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05696171
Brief Title
Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
Acronym
ROBIICCA
Official Title
Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Profound Bilateral Hearing Loss
Keywords
Profound hearing loss, cochlear implant, RobOtol®

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual insertion
Arm Type
Active Comparator
Arm Description
Manual insertion of the cochlear implant
Arm Title
Robotized insertion
Arm Type
Experimental
Arm Description
Robotic insertion of the cochlear implant
Intervention Type
Procedure
Intervention Name(s)
Cochlear implant manual insertion
Intervention Description
Manual insertion of the cochlear implant into the round window during the surgery
Intervention Type
Procedure
Intervention Name(s)
Cochlear implant robotized insertion
Intervention Description
Robotic insertion of the cochlear implant into the round window during the surgery
Primary Outcome Measure Information:
Title
Speech discrimination score
Description
the speech discrimination score is the percentage of repeated words in silence, with a monosyllabic list, at 60dB, cochlear implant activated.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Speech discrimination score
Description
Speech discrimination score (percent of words recognized in monosyllabic list) at 60 dB
Time Frame
Baseline, 6 months
Title
Speech Reception Threshold (SRT 50)
Description
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).
Time Frame
6 months, 12 months
Title
Speech audiometry in noise
Description
Signal to Noise Ratio to achieve 50% or 80% intelligibility (SNR50 and SNR80) with the Fra-Matrix noise test
Time Frame
6 months, 12 months
Title
Rate of incomplete insertion
Description
Number of electrodes inserted at immediate post-operative imaging by Cone Beam or CT scan.
Time Frame
Day one post operative
Title
Rate of electrode translocations
Description
Analysis of translocations using software measures after Cone beam or CT scan (blinded centralized analysis)
Time Frame
Day one post operative
Title
Residual hearing
Description
Pure Tone Audiometry thresholds, implant deactivated, at 250, 500, 1000, 2000 and 4000 Hz (mean of the 5 frequencies)
Time Frame
Baseline, 6 months, 12 months
Title
Pure-tone audiometry
Description
Pure Tone Audiometry thresholds, implant activated, at 250, 500, 1000, 2000 and 4000 Hz (mean of the 5 frequencies)
Time Frame
6 months, 12 months
Title
Complications related to the implant
Description
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)
Time Frame
Day one, 1 month, 3 months, 6 months, 12 months
Title
Quality of life of patients with HUI3
Description
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.
Time Frame
Baseline, one month, 3 months, 6 months, 12 months
Title
Quality of life of patients with EQ-5D
Description
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.
Time Frame
Baseline, one month, 3 months, 6 months, 12 months
Title
Vestibular function with VHIT
Description
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.
Time Frame
Baseline, 12 months
Title
Vestibular function with Caloric test results
Description
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.
Time Frame
Baseline, 12 months
Title
Vestibular function with MVEP
Description
Myogenic Vestibular Evoked Potential (MVEP) detects the presence of reproductible waveforms of normal morphology in latency and amplitude
Time Frame
Baseline, 12 months
Title
Incremental cost-effectiveness ratio (cost per point of speech discrimination score gain) from a collective perspective
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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®)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume MICHEL, PhD
Phone
+33.2.40.08.34.75
Email
guillaume.michel@chu-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile Dert
Phone
+33253482852
Email
cecile.dert@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume MICHEL
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lille University Hospital
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael RISOUD
First Name & Middle Initial & Last Name & Degree
Michael RISOUD
Facility Name
Bordeaux University Hospital
City
Bordeaux
ZIP/Postal Code
33604
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien BONNARD
First Name & Middle Initial & Last Name & Degree
Damien BONNARD, Pr
Facility Name
Brest University Hospital
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rémi MARIANOWSKI, MD, PhD
First Name & Middle Initial & Last Name & Degree
Rémi MARIANOWSKI
Facility Name
Chu Clermont Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry MOM
First Name & Middle Initial & Last Name & Degree
Thierry MOM, Pr
Facility Name
Hopital Bicetre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme NEVOUX
First Name & Middle Initial & Last Name & Degree
Jérôme NEVOUX
Facility Name
AP-HM
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane Roman
First Name & Middle Initial & Last Name & Degree
Stephane Roman
Facility Name
CHRU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric VENAIL
First Name & Middle Initial & Last Name & Degree
Frédéric VENAIL
Facility Name
Michel
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume MICHEL, MD
Email
guillaume.michel@chu-nantes.fr
Facility Name
CHU NICE
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas GUEVARA
First Name & Middle Initial & Last Name & Degree
Nicolas GUEVARA
Facility Name
AP-HP - la Pitié-Salpétrière
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann NGUYEN, Profesor
First Name & Middle Initial & Last Name & Degree
Yann NGUYEN
Facility Name
C.H.R. Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit GODEY, MD
First Name & Middle Initial & Last Name & Degree
Benoit GODEY
Facility Name
CHU de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre KARKAS
First Name & Middle Initial & Last Name & Degree
Alexandre KARKAS
Facility Name
CHRU Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Charpiot
First Name & Middle Initial & Last Name & Degree
anne Charpiot, MD
Facility Name
CHRU de Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David BAKHOS
First Name & Middle Initial & Last Name & Degree
David BAKHOS

12. IPD Sharing Statement

Learn more about this trial

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

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