DeafnessHEARO-ATNCT04795986
First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria
An observational study of Deafness, run by Medical University of Vienna at 1 site in Austria.
Trial summary
To demonstrate the efficacy of a minimally invasive direct cochlear access via the HEARO procedure in cochlear implantation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Deafness
- What is being tested?
- HEARO Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 17 Sep 2021to Dec 2023
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.
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
- Pregnant women
- Facial recess size does not allow a minimum distance of 0.4mm from the planned trajectory to the facial nerve and 0.3mm to the chorda tympani
- Vulnerable or mentally retarded candidates
- Invalid or withdrawn informed consent
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
HNO Klinik am AKH Wien
Vienna, State of Vienna, 1090
Kliniksekretariat HNO Klinik, +43 1 40400 33760, klinsek@push-email.at
About this study
To demonstrate the efficacy of a minimally invasive direct cochlear access via the HEARO procedure in cochlear implantation.
Read the detailed description
The HEARO procedure involves a robot which drills the access to the cochlear in cochlear implantation.
The study is an observational study of the first implementation in clinical routine in Austria.
- Conditions
- Deafness
- Being tested
- HEARO Procedure
- Keywords
- cochlear implantation, robotic surgery, automated inner ear access, automated middle ear access
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEARO ProcedureProcedure or surgery
robotic access to the middle and inner ear in cochlear implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of cochlear access
Percentage of patients with successful cochlear access with the hearo procedure (successful meaning no conventional mastoidectomy and posterior tympanotomy necessary)
Measured: at implantation
Secondary outcomes (2)
electrode array insertion outcomes
Percentage of patients with full electrode insertion (all contacts inside the cochlea) as assessed by postoperative DVT Imaging
Measured: at implantation
Safety of cochlear access
Number of patients with facial nerve paralysis after cochlear implantation as assessed by the House-Brackmann scale.
Measured: at implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start17 Sep 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- MED-EL Elektromedizinische Geräte GmbH
- Responsible party
- Principal investigator, Christoph Arnoldner, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795986
- Sponsor's protocol ID
- HEARO-AT
- Acronym
- HEARO-AT
- Status last verified
- Sep 2021
- First submitted
- 22 Feb 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria
- ClinicalTrials.gov ID
- NCT04795986
- Acronym / sponsor ID
- HEARO-AT / HEARO-AT
- Conditions
- Deafness
- Keywords
- cochlear implantation, robotic surgery, automated inner ear access, automated middle ear access
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- MED-EL Elektromedizinische Geräte GmbH
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Mar 2021 (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 demonstrate the efficacy of a minimally invasive direct cochlear access via the HEARO procedure in cochlear implantation.
Detailed description
The HEARO procedure involves a robot which drills the access to the cochlear in cochlear implantation.
The study is an observational study of the first implementation in clinical routine in Austria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.
Key inclusion criteria (1 listed)
- Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.
Key exclusion criteria (5 listed)
- Age under 18 years
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 |
|---|---|---|
| HEARO Procedurerobotic access to the middle and inner ear in cochlear implantation | Procedure or surgery | – |
Primary outcome
efficacy of cochlear access
Time frame: at implantation
Percentage of patients with successful cochlear access with the hearo procedure (successful meaning no conventional mastoidectomy and posterior tympanotomy necessary)
2 secondary outcomes
electrode array insertion outcomes
Time frame: at implantation
Safety of cochlear access
Time frame: at implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deafness, run by Medical University of Vienna at 1 site in Austria.
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 5 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 28 Sep 2021. 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 Austria. 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 Kliniksekretariat HNO Klinik (+43 1 40400 33760, klinsek@push-email.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of cochlear access (time frame: at implantation). 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 28 Sep 2021.