Cochlear Hearing LossROSA-ICNCT04048239
Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation
A study testing cochlear implantation, computerized tomography (CT) scan and electromyograph in people with Cochlear Hearing Loss and Implant, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Hearing Loss, Implant
- What is being tested?
- cochlear implantation, computerized tomography (CT) scan and electromyograph
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 12 Sep 2023
- 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
- patients eligible for cochlear implantation in CHU Amiens
- patient more than 18 years old.
Who cannot join
- malformation or significant antecedent of mastoidectomy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Cochlear Hearing Loss, Implant
- Being tested
- cochlear implantation, computerized tomography (CT) scan, electromyograph
- Keywords
- cochlear implant, robotic, mini-invasive
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cochlear implantationProcedure or surgery
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) scanOther
computerized tomography (CT) scan of the facial nerve
electromyographOther
electromyographic verification of the facial nerve
What is being measured
The primary outcome is the main question the study is designed to answer.
cochlear implantation with the ROSA robot surgery time
cochlear implantation with the ROSA robot surgery time
Measured: during surgery, day 1
surgical quality based on material description and surgical technique
surgical quality based on material description and surgical technique
Measured: during surgery, day 1
Secondary outcomes (4)
surgical quality based on robot precision
surgical quality based on robot precision
Measured: during surgery, day 1
surgical quality based on the cochlear implantation in the cochlea
surgical quality based on the cochlear implantation in the cochlea
Measured: during surgery, day 1
surgical quality based on intraoperative electrophysiological data
surgical quality based on intraoperative electrophysiological data
Measured: during surgery, day 1
surgical quality based on pathological complications
surgical quality based on pathological complications (facial, paralysis, infection, pain)
Measured: during surgery and postoperative period (1.5 month after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Oct 2019
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cochlear Hearing LossStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie klopp-Dutote, MD, Principal investigator, CHU amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048239
- Sponsor's protocol ID
- PI2019_843_0004
- Acronym
- ROSA-IC
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2019
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klopp-Dutote N, Lefranc M, Strunski V, Page C. Minimally invasive fully ROBOT-assisted cochlear implantation in humans: Preliminary results in five consecutive patients. Clin Otolaryngol. 2021 Nov;46(6):1326-1330. doi: 10.1111/coa.13840. Epub 2021 Aug 17. No abstract available.
PubMed 34310841
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation
- ClinicalTrials.gov ID
- NCT04048239
- Acronym / sponsor ID
- ROSA-IC / PI2019_843_0004
- Conditions
- Cochlear Hearing Loss, Implant
- Keywords
- cochlear implant, robotic, mini-invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 7 Aug 2019 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients eligible for cochlear implantation in CHU Amiens
- patient more than 18 years old.
Key exclusion criteria (1 listed)
- malformation or significant antecedent of mastoidectomy
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 implantationcochlear 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. | Procedure or surgery | – |
| computerized tomography (CT) scancomputerized tomography (CT) scan of the facial nerve | Other | – |
| electromyographelectromyographic verification of the facial nerve | Other | – |
Primary outcome
cochlear implantation with the ROSA robot surgery time
Time frame: during surgery, day 1
cochlear implantation with the ROSA robot surgery time
surgical quality based on material description and surgical technique
Time frame: during surgery, day 1
surgical quality based on material description and surgical technique
4 secondary outcomes
surgical quality based on robot precision
Time frame: during surgery, day 1
surgical quality based on the cochlear implantation in the cochlea
Time frame: during surgery, day 1
surgical quality based on intraoperative electrophysiological data
Time frame: during surgery, day 1
surgical quality based on pathological complications
Time frame: during surgery and postoperative period (1.5 month after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 34310841Klopp-Dutote N, Lefranc M, Strunski V, Page C. Minimally invasive fully ROBOT-assisted cochlear implantation in humans: Preliminary results in five consecutive patients. Clin Otolaryngol. 2021 Nov;46(6):1326-1330. doi: 10.1111/coa.13840. Epub 2021 Aug 17. No abstract available.
- Individual participant dataSharing planned: No
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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.
Nathalie klopp-Dutote, MD principal investigator
CHU amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cochlear implantation, computerized tomography (CT) scan and electromyograph in people with Cochlear Hearing Loss and Implant, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cochlear implantation with the ROSA robot surgery time (time frame: during surgery, day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048239, which also lists 1 linked publication.
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 19 Sep 2025.