Sensorineural Hearing LossARCI25NCT04102215
The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure
A study testing HEARO and OTOPLAN in people with Sensorineural Hearing Loss, run by Prof. Vedat Topsakal at 1 site in Belgium.
Trial summary
To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure. 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
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2019to 4 Nov 2020
- 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 cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.
Who cannot join
- Age under 18 years
- Pregnancy
- Distance of the planned trajectory to the facial nerve is < 0.4mm
- Distance of the planned trajectory to the chorda tympani is < 0.3mm
- Vulnerability
- Invalid or withdrawn informed consent
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Antwerp
Vedat Topsakal, Prof, 003238213245, vedat.topsakal@uza.be
Vedat Topsakal, Prof
About this study
To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.
- 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
Also called HEARO procedures
Robotic system for otological procedures
OTOPLANDevice
Otological surgical planning software
| Study group | Role | What they receive |
|---|---|---|
| ARCI25 | Experimental | Robot assited 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.
The relative ratio of the electrode array insertion into the cochlea through the drilled direct cochlea access with HEARO procedure. (Efficacy)
The ratio of the number of the procedures in which it was possible to insert the electrode inside the cochlea through the direct cochlear access compared to the number of procedures in which the insertion through the direct cochlea access was not possible will be calculated. 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 (n of 25) and in percentage (%).
Measured: Image data aquired during the procedure
Secondary outcomes (7)
Electrode array insertion depth (Efficacy)
The electrode insertion depth will be measured in the post-operative image. (Degrees °)
Measured: The procedure (day 0)
Number of correctlly inserted electrode contact (Efficacy)
The number of inserted electrode contacts into the inner ear will be counted in the post-operative image. (Number n)
- number of contacts inserted (n)
Measured: The procedure (day 0)
Insertion depth prediction accuracy (Efficacy)
The insertion depth prediction accuracy as the difference between the estimated insertion depth of the electrode at the planning and the actual insertion depth. (Degrees °)
Measured: The procedure (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 and the actual angles.
Measured: The procedure (day 0)
Absolute lateral drilling accuracy of the drilled tunnel at the level of facial recess (Safety)
The absolute lateral accuracy of the drilled tunnel to the facial nerve and chorda tympani is measured as the difference between the planned and the actual distance. (mm)
Measured: The procedure (day 0)
Absolute lateral drilling accuracy of the drilled tunnel at the target (Safety)
The absolute lateral accuracy of the drilled tunnel is measured as the distance between the planned and actual target position. (mm)
Measured: The procedure (day 0)
Evaluation of the automatic landmark detection (Performance)
The relative ratio of the automatically identified landmarks by OTOPLAN that were not manually adjusted by the surgeon. The intended landmarks are:
- Middle ear cavity breakthrough
- Bony overhang lateral wall
- Bony overhang medial wall The absolute distance between the new position of the adjusted landmark to the position of the automatically identified landmark will be evaluated. (Number n)
Measured: The procedure (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Sep 2019
- Primary completion3 Sep 2020
- Study completion4 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Model description
- SIngle arm study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
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
- NCT04102215
- Sponsor's protocol ID
- 000523
- Acronym
- ARCI25
- Status last verified
- Oct 2020
- First submitted
- 22 Sep 2019
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heuninck E, Van de Heyning P, Van Rompaey V, Mertens G, Topsakal V. Audiological outcomes of robot-assisted cochlear implant surgery. Eur Arch Otorhinolaryngol. 2023 Oct;280(10):4433-4444. doi: 10.1007/s00405-023-07961-7. Epub 2023 Apr 12.
PubMed 37043021Topsakal 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 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure
- ClinicalTrials.gov ID
- NCT04102215
- Acronym / sponsor ID
- ARCI25 / 000523
- Conditions
- Sensorineural Hearing Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Prof. Vedat TopsakalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 4 Nov 2020 (estimated)
- First posted
- 25 Sep 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.
To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SIngle arm study
| Arm | Type | Receives |
|---|---|---|
| ARCI25 | Experimental | Device: HEARO, Device: OTOPLANRobot assited 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 (1 listed)
- Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.
Key exclusion criteria (6 listed)
- Age under 18 years
- Pregnancy
- Distance of the planned trajectory to the facial nerve is < 0.4mm
- Distance of the planned trajectory to the chorda tympani is < 0.3mm
- Vulnerability
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 proceduresRobotic system for otological procedures | Device | ARCI25 |
| OTOPLANOtological surgical planning software | Device | ARCI25 |
Primary outcome
The relative ratio of the electrode array insertion into the cochlea through the drilled direct cochlea access with HEARO procedure. (Efficacy)
Time frame: Image data aquired during the procedure
The ratio of the number of the procedures in which it was possible to insert the electrode inside the cochlea through the direct cochlear access compared to the number of procedures in which the insertion through the direct cochlea access was not possible will be calculated. 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 (n of 25) and in percentage (%).
7 secondary outcomes
Electrode array insertion depth (Efficacy)
Time frame: The procedure (day 0)
Number of correctlly inserted electrode contact (Efficacy)
Time frame: The procedure (day 0)
Insertion depth prediction accuracy (Efficacy)
Time frame: The procedure (day 0)
Absolute angular accuracy of the drilled tunnel access
Time frame: The procedure (day 0)
Absolute lateral drilling accuracy of the drilled tunnel at the level of facial recess (Safety)
Time frame: The procedure (day 0)
Absolute lateral drilling accuracy of the drilled tunnel at the target (Safety)
Time frame: The procedure (day 0)
Evaluation of the automatic landmark detection (Performance)
Time frame: The procedure (day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Derived from this study: PubMed 37043021Heuninck E, Van de Heyning P, Van Rompaey V, Mertens G, Topsakal V. Audiological outcomes of robot-assisted cochlear implant surgery. Eur Arch Otorhinolaryngol. 2023 Oct;280(10):4433-4444. doi: 10.1007/s00405-023-07961-7. Epub 2023 Apr 12.
- 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.
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 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 6 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 6 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vedat Topsokal, Prof (003238213245, vedat.topsakal@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relative ratio of the electrode array insertion into the cochlea through the drilled direct cochlea access with HEARO procedure. (Efficacy) (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 NCT04102215, which also lists 2 linked publications.
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 6 Oct 2020.