Sensorineural Hearing LossNCT04610450
The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation
A study testing HEARO and OTOPLAN in people with Sensorineural Hearing Loss, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- HEARO and OTOPLAN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Apr 2021to 23 Nov 2022
- 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
- Subjects scheduled for CI surgery according to clinical routine
- Subjects who will receive a cochlear implant
- Signed and dated informed consent form
Who cannot join
- Lack of compliance with any inclusion criteria
- Age under 18 years
- Pregnancy
- Distance of the planned trajectory to the facial nerve is < 0.4 mm as per screening CT scan
- Distance of the planned trajectory to the chorda tympani is < 0.3 mm as per screening CT scan
- A safe inner ear access cannot be planned for preservation of RW membrane and cochlear structures
- Individuals where image guidance or robotic procedures are not indicated
Trial locations and contacts
1 site in 1 country.
About this study
The cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. However, due to the location of the cochlea inside the skull, the surgeon is required to create an access from the surface of the temporal bone to the cochlea (inner ear). In conventional methods, this access is acquired by removal of portions of the mastoid bone through a mastoidectomy and posterior tympanotomy. The outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation. To overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place. This study primarily aims to explore the performance of robotic cochlear implantation surgery.
- Conditions
- Sensorineural Hearing Loss
- Being tested
- HEARO, OTOPLAN
- 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.
HEARODevice
Robotic system for otological procedures
OTOPLANDevice
Otological surgical planning software
| Study group | Role | What they receive |
|---|---|---|
| RCI-BE-10 | Experimental | Robot assisted cochlear implant surgery. Receives: Device: HEARO; Device: OTOPLAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures.
The primary outcome measure of this study is to explore the relative ratio of the successful electrode array insertions into the cochlea through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures. Aborted or converted procedures count as procedure in which insertion through the direct cochlea access was not possible. The results will be expressed in relative numbers and in percentage.
Measured: day 0
Secondary outcomes (9)
Electrode array insertion outcome
The angular insertion depth (in degrees) will be evaluated.
Measured: day 0
Electrode array insertion outcome
The number of inserted electrode contacts will be evaluated.
Measured: day 0
Electrode array insertion outcome
The surgical outcome (categories: nominal, tip-fold over or scalar deviation) will be evaluated.
Measured: day 0
Insertion depth prediction accuracy
The insertion depth prediction accuracy as the difference between the estimated insertion depth of the electrode at the planning and the actual insertion depth.
Measured: day 0
Absolute angular accuracy of the drilled tunnel access
The absolute in-plane and out-plane accuracy of the drilled tunnel is measured as the angular deviation between the planned trajectory in-plane and out-plane angles and the actual drilled angles from the intra-op image.
Measured: day 0
Absolute lateral accuracy of the drilled tunnel at the facial recess
The absolute lateral accuracy of the drilled tunnel to the facial nerve and chorda tympani is measured as the difference between the planned trajectory and the actual drilled trajectory distance.
Measured: day 0
Absolute lateral accuracy of the drilled tunnel at the target
The absolute lateral accuracy of the drilled tunnel is measured as the distance between the planned target trajectory position and actual target of the drilled trajectory position.
Measured: day 0
Ratio of the round window membrane preservation during the inner ear access
The ratio of the visibility of round window membrane surface at the robotic inner ear access by visual inspection. This will be assessed as subjective evaluation by the surgeon.
Measured: day 0
Timing of the HEARO procedure
The timing of the different steps of the HEARO procedure will be recorded.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start26 Apr 2021
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Caversaccio, Prof. Dr., Principal investigator, University Hospital Bern (Inselspital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610450
- Sponsor's protocol ID
- RCI-NEXT
- Status last verified
- May 2022
- First submitted
- 22 Oct 2020
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation
- ClinicalTrials.gov ID
- NCT04610450
- Acronym / sponsor ID
- RCI-NEXT
- Conditions
- Sensorineural Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 30 Oct 2020 (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 cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. However, due to the location of the cochlea inside the skull, the surgeon is required to create an access from the surface of the temporal bone to the cochlea (inner ear). In conventional methods, this access is acquired by removal of portions of the mastoid bone through a mastoidectomy and posterior tympanotomy. The outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation. To overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place. This study primarily aims to explore the performance of robotic cochlear implantation surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RCI-BE-10 | Experimental | Device: HEARO, Device: OTOPLANRobot assisted cochlear implant surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects scheduled for CI surgery according to clinical routine
- Subjects who will receive a cochlear implant
- Signed and dated informed consent form
Key exclusion criteria (7 listed)
- Lack of compliance with any inclusion criteria
- Age under 18 years
- Pregnancy
- Distance of the planned trajectory to the facial nerve is < 0.4 mm as per screening CT scan
- Distance of the planned trajectory to the chorda tympani is < 0.3 mm as per screening CT scan
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 |
|---|---|---|
| HEARORobotic system for otological procedures | Device | RCI-BE-10 |
| OTOPLANOtological surgical planning software | Device | RCI-BE-10 |
Primary outcome
Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures.
Time frame: day 0
The primary outcome measure of this study is to explore the relative ratio of the successful electrode array insertions into the cochlea through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures. Aborted or converted procedures count as procedure in which insertion through the direct cochlea access was not possible. The results will be expressed in relative numbers and in percentage.
9 secondary outcomes
Electrode array insertion outcome
Time frame: day 0
Electrode array insertion outcome
Time frame: day 0
Electrode array insertion outcome
Time frame: day 0
Insertion depth prediction accuracy
Time frame: day 0
Absolute angular accuracy of the drilled tunnel access
Time frame: day 0
Absolute lateral accuracy of the drilled tunnel at the facial recess
Time frame: day 0
Absolute lateral accuracy of the drilled tunnel at the target
Time frame: day 0
Ratio of the round window membrane preservation during the inner ear access
Time frame: day 0
Timing of the HEARO procedure
Time frame: day 0
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 25 Nov 2022.
- 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.
Marco Caversaccio, Prof. Dr. principal investigator
University Hospital Bern (Inselspital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEARO and OTOPLAN in people with Sensorineural Hearing Loss, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 7 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 25 Nov 2022. 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 Switzerland. 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?
Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures. (time frame: day 0). 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 25 Nov 2022.