Sensorineural Hearing LossEAR2OSNCT03746613
Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
A study testing HEARO in people with Sensorineural Hearing Loss, run by Prof. Vedat Topsakal at 1 site in Belgium.
Trial summary
To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Sep 2018to 1 Jun 2019
- 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 suffering from profound sensorineural deafness requiring a Cochlear implant
Who cannot join
- Age under 18 years
- Pregnant women
- Anatomical anomalies of temporal bone
- Chronic otitis media with or without cholesteatoma
Trial locations and contacts
1 site in 1 country.
About this study
To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.
Read the detailed description
- Demonstrate the feasibility and efficacy of performing a middle and inner ear access for cochlear implantation procedures in adults.
- Validate the procedure workflow including imaging, planning, safety assessment, image to patient registration, robotic drilling, electrode insertion and device implantation.
- Validate the system and procedure safety mechanisms.
- Collect required data for validation of safety algorithms and procedure workflow optimisation.
- Validate the HEARO system.
- Conditions
- Sensorineural Hearing Loss
- Being tested
- HEARO
- Keywords
- robot, Image guidance, Cochlear implantation, navigation, HEARO procedure, sensorineural hearing loss, inner ear access
- 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
Also called HEARO procedure
Robotic system for otological procedures
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive robotic cochlear implantation with HEARO | Experimental | Not described Receives: Device: HEARO |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative ratio of successfully completed procedures where a direct access tunnel was drilled to the cochlea with the HEARO® system and the electrode was conventionally inserted through the tunnel.
Measured: Image data aquired during the procedure
Secondary outcomes (10)
Number of completed middle ear access
Measured: The procedure (day 0)
Number of completed inner ear access
Measured: The procedure (day 0)
Accuracy of the drilled trajectory
Measured: Image data aquired during the procedure
Sensitivity and specificity of facial nerve monitoring
Measured: The procedure (day 0)
Measurement of the insertion angle
Measurement of the insertion depth of the electrode into the Cochlea
Measured: Image data aquired during the procedure
Number of tip fold-overs
Measured: The procedure (day 0)
Number of Scala deviations
Measured: The procedure (day 0)
Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection
Measured: day 0-30
Time of procedure
Measured: The procedure (day 0)
Volume of tissue removed
Measured: Image data aquired during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start24 Sep 2018
- Primary completion27 Apr 2019
- Study completion1 Jun 2019
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 Sensorineural Hearing LossStudies of the same condition, open and under way.
- 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
- Prof. Vedat Topsakal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Vedat Topsakal, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746613
- Sponsor's protocol ID
- B300201837507
- Acronym
- EAR2OS
- Status last verified
- Jul 2019
- First submitted
- 12 Nov 2018
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Topsakal V, Heuninck E, Matulic M, Tekin AM, Mertens G, Van Rompaey V, Galeazzi P, Zoka-Assadi M, van de Heyning P. First Study in Men Evaluating a Surgical Robotic Tool Providing Autonomous Inner Ear Access for Cochlear Implantation. Front Neurol. 2022 Mar 21;13:804507. doi: 10.3389/fneur.2022.804507. eCollection 2022.
PubMed 35386404
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
- ClinicalTrials.gov ID
- NCT03746613
- Acronym / sponsor ID
- EAR2OS / B300201837507
- Conditions
- Sensorineural Hearing Loss
- Keywords
- robot, Image guidance, Cochlear implantation, navigation, HEARO procedure, sensorineural hearing loss, inner ear access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Prof. Vedat TopsakalUniversity, hospital or other
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 27 Apr 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 19 Nov 2018 (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.
To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.
Detailed description
- Demonstrate the feasibility and efficacy of performing a middle and inner ear access for cochlear implantation procedures in adults.
- Validate the procedure workflow including imaging, planning, safety assessment, image to patient registration, robotic drilling, electrode insertion and device implantation.
- Validate the system and procedure safety mechanisms.
- Collect required data for validation of safety algorithms and procedure workflow optimisation.
- Validate the HEARO system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive robotic cochlear implantation with HEARO | Experimental | Device: HEARO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering from profound sensorineural deafness requiring a Cochlear implant
Key exclusion criteria (4 listed)
- Age under 18 years
- Pregnant women
- Anatomical anomalies of temporal bone
- Chronic otitis media with or without cholesteatoma
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 |
|---|---|---|
| HEAROAlso: HEARO procedureRobotic system for otological procedures | Device | Minimally invasive robotic cochlear implantation with HEARO |
Primary outcome
The relative ratio of successfully completed procedures where a direct access tunnel was drilled to the cochlea with the HEARO® system and the electrode was conventionally inserted through the tunnel.
Time frame: Image data aquired during the procedure
10 secondary outcomes
Number of completed middle ear access
Time frame: The procedure (day 0)
Number of completed inner ear access
Time frame: The procedure (day 0)
Accuracy of the drilled trajectory
Time frame: Image data aquired during the procedure
Sensitivity and specificity of facial nerve monitoring
Time frame: The procedure (day 0)
Measurement of the insertion angle
Time frame: Image data aquired during the procedure
Number of tip fold-overs
Time frame: The procedure (day 0)
Number of Scala deviations
Time frame: The procedure (day 0)
Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection
Time frame: day 0-30
Time of procedure
Time frame: The procedure (day 0)
Volume of tissue removed
Time frame: Image data aquired during the procedure
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 24 Jul 2019.
- Derived from this study: PubMed 35386404Topsakal V, Heuninck E, Matulic M, Tekin AM, Mertens G, Van Rompaey V, Galeazzi P, Zoka-Assadi M, van de Heyning P. First Study in Men Evaluating a Surgical Robotic Tool Providing Autonomous Inner Ear Access for Cochlear Implantation. Front Neurol. 2022 Mar 21;13:804507. doi: 10.3389/fneur.2022.804507. eCollection 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Sensorineural Hearing Loss, run by Prof. Vedat Topsakal at 1 site in Belgium.
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 1 inclusion and 4 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 24 Jul 2019. 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 Belgium. 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?
The relative ratio of successfully completed procedures where a direct access tunnel was drilled to the cochlea with the HEARO® system and the electrode was conventionally inserted through the tunnel. (time frame: Image data aquired during the procedure). 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 NCT03746613, 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 24 Jul 2019.