Profound Bilateral Hearing LossROBIICCANCT05696171
Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
A study testing Cochlear implant manual insertion and Cochlear implant robotized insertion in people with Profound Bilateral Hearing Loss, run by Nantes University Hospital at 14 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Profound Bilateral Hearing Loss
- What is being tested?
- Cochlear implant manual insertion and Cochlear implant robotized insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 14 sitesFrance
- Study dates
- 2 May 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (age > 18)
- Eligible for a cochlear implant insertion according to the HAS recommendations
- Patient having signed an informed consent
Who cannot join
- 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.
Show all 10Show fewer
- 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®)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites, 14 recruiting
- Not yet recruiting
Bordeaux University Hospital
Bordeaux, 33604
Damien BONNARD
Damien BONNARD, Pr
- Recruiting
Brest University Hospital
Brest
Rémi MARIANOWSKI, MD, PhD
Rémi MARIANOWSKI
- Recruiting
Chu Clermont Ferrand
Clermont-Ferrand
Thierry MOM
Thierry MOM, Pr
- Recruiting
Hopital Bicetre
Le Kremlin-Bicêtre, 94270
Jérôme NEVOUX
Jérôme NEVOUX
- Recruiting
Lille University Hospital
Lille, Nord, 59000
Michael RISOUD
Michael RISOUD
- Not yet recruiting
AP-HM
Marseille
Stephane Roman
Stephane Roman
- Not yet recruiting
CHRU de Montpellier
Montpellier
Frédéric VENAIL
Frédéric VENAIL
- Recruiting
Michel
Nantes
Guillaume MICHEL, MD, guillaume.michel@chu-nantes.fr
- Recruiting
CHU NICE
Nice
Nicolas GUEVARA
Nicolas GUEVARA
- Not yet recruiting
AP-HP - la Pitié-Salpétrière
Paris
Yann NGUYEN, Profesor
Yann NGUYEN
- Not yet recruiting
C.H.R. Pontchaillou
Rennes, 35033
Benoit GODEY, MD
Benoit GODEY
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42270
Alexandre KARKAS
Alexandre KARKAS
- Not yet recruiting
CHRU Hautepierre
Strasbourg, 67098
Anne Charpiot
anne Charpiot, MD
- Not yet recruiting
CHRU de Tours
Tours, 37000
David BAKHOS
David BAKHOS
About this study
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.
Read the 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.
- Conditions
- Profound Bilateral Hearing Loss
- Being tested
- Cochlear implant manual insertion, Cochlear implant robotized insertion
- Keywords
- Profound hearing loss, cochlear implant, RobOtol®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implant manual insertionProcedure or surgery
Manual insertion of the cochlear implant into the round window during the surgery
Cochlear implant robotized insertionProcedure or surgery
Robotic insertion of the cochlear implant into the round window during the surgery
| Study group | Role | What they receive |
|---|---|---|
| Manual insertion | Active comparator | Manual insertion of the cochlear implant Receives: Procedure: Cochlear implant manual insertion |
| Robotized insertion | Experimental | Robotic insertion of the cochlear implant Receives: Procedure: Cochlear implant robotized insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech discrimination score
the speech discrimination score is the percentage of repeated words in silence, with a monosyllabic list, at 60dB, cochlear implant activated.
Measured: 1 year
Secondary outcomes (14)
Speech discrimination score
Speech discrimination score (percent of words recognized in monosyllabic list) at 60 dB
Measured: 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).
Measured: 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
Measured: 6 months, 12 months
Rate of incomplete insertion
Number of electrodes inserted at immediate post-operative imaging by Cone Beam or CT scan.
Measured: Day one post operative
Rate of electrode translocations
Analysis of translocations using software measures after Cone beam or CT scan (blinded centralized analysis)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start2 May 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Profound Bilateral Hearing LossStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume MICHEL, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696171
- Sponsor's protocol ID
- RC22_0384
- Acronym
- ROBIICCA
- Status last verified
- May 2023
- First submitted
- 13 Jan 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
- ClinicalTrials.gov ID
- NCT05696171
- Acronym / sponsor ID
- ROBIICCA / RC22_0384
- Conditions
- Profound Bilateral Hearing Loss
- Keywords
- Profound hearing loss, cochlear implant, RobOtol®
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual insertion | Active comparator | Procedure: Cochlear implant manual insertionManual insertion of the cochlear implant |
| Robotized insertion | Experimental | Procedure: Cochlear implant robotized insertionRobotic insertion of the cochlear implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient (age > 18)
- Eligible for a cochlear implant insertion according to the HAS recommendations
- Patient having signed an informed consent
Key exclusion criteria (10 listed)
- 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®:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear implant manual insertionManual insertion of the cochlear implant into the round window during the surgery | Procedure or surgery | Manual insertion |
| Cochlear implant robotized insertionRobotic insertion of the cochlear implant into the round window during the surgery | Procedure or surgery | Robotized insertion |
Primary outcome
Speech discrimination score
Time frame: 1 year
the speech discrimination score is the percentage of repeated words in silence, with a monosyllabic list, at 60dB, cochlear implant activated.
14 secondary outcomes
Speech discrimination score
Time frame: Baseline, 6 months
Speech Reception Threshold (SRT 50)
Time frame: 6 months, 12 months
Speech audiometry in noise
Time frame: 6 months, 12 months
Rate of incomplete insertion
Time frame: Day one post operative
Rate of electrode translocations
Time frame: Day one post operative
Residual hearing
Time frame: Baseline, 6 months, 12 months
Pure-tone audiometry
Time frame: 6 months, 12 months
Complications related to the implant
Time frame: Day one, 1 month, 3 months, 6 months, 12 months
Quality of life of patients with HUI3
Time frame: Baseline, one month, 3 months, 6 months, 12 months
Quality of life of patients with EQ-5D
Time frame: Baseline, one month, 3 months, 6 months, 12 months
Vestibular function with VHIT
Time frame: Baseline, 12 months
Vestibular function with Caloric test results
Time frame: Baseline, 12 months
Vestibular function with MVEP
Time frame: Baseline, 12 months
Incremental cost-effectiveness ratio (cost per point of speech discrimination score gain) from a collective perspective
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
Related trials for Profound Bilateral Hearing Loss
RecruitingObservational study
Natural History in Children up to 16 Years With Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes
Sensorineural Hearing Loss, Bilateral, AUNB1
Active, not recruiting
Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
Sensori-Neural Deafness, Sensorineural Hearing Loss
Not yet recruiting
Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.
Hearing Loss, Sensorineural
Not yet recruitingObservational study
Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume MICHEL principal investigator
Nantes University Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear implant manual insertion and Cochlear implant robotized insertion in people with Profound Bilateral Hearing Loss, run by Nantes University Hospital at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume MICHEL, PhD (+33.2.40.08.34.75, guillaume.michel@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech discrimination score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.