- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04102215
The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure (ARCI25)
October 4, 2020 updated by: Prof. Vedat Topsakal
To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vedat Topsokal, Prof
- Phone Number: 003238213245
- Email: vedat.topsakal@uza.be
Study Contact Backup
- Name: Paul Van de Heyning, Prof
- Phone Number: 003238213245
- Email: Paul.VandeHeyning@uza.be
Study Locations
-
-
-
Antwerp, Belgium
- Recruiting
- Antwerp University Hospital
-
Contact:
- Vedat Topsakal, Prof
- Phone Number: 003238213245
- Email: vedat.topsakal@uza.be
-
Principal Investigator:
- Vedat Topsakal, Prof
-
Sub-Investigator:
- Paul van de Heyning, Prof
-
Sub-Investigator:
- Marco Matulic
-
Sub-Investigator:
- Vincent Van Rompaey, Prof
-
Sub-Investigator:
- Griet Mertens, Prof
-
Sub-Investigator:
- Masoud Zoka Assadi, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.
Exclusion Criteria:
- 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- Invalid or withdrawn informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ARCI25
Robot assited Cochlear implant surgery.
|
Robotic system for otological procedures
Other Names:
Otological surgical planning software
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 (%).
|
Image data aquired during the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electrode array insertion depth (Efficacy)
Time Frame: The procedure (day 0)
|
The electrode insertion depth will be measured in the post-operative image.
(Degrees °)
|
The procedure (day 0)
|
Number of correctlly inserted electrode contact (Efficacy)
Time Frame: The procedure (day 0)
|
The number of inserted electrode contacts into the inner ear will be counted in the post-operative image. (Number n)
|
The procedure (day 0)
|
Insertion depth prediction accuracy (Efficacy)
Time Frame: The procedure (day 0)
|
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 °)
|
The procedure (day 0)
|
Absolute angular accuracy of the drilled tunnel access
Time Frame: The procedure (day 0)
|
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.
|
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)
|
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)
|
The procedure (day 0)
|
Absolute lateral drilling accuracy of the drilled tunnel at the target (Safety)
Time Frame: The procedure (day 0)
|
The absolute lateral accuracy of the drilled tunnel is measured as the distance between the planned and actual target position.
(mm)
|
The procedure (day 0)
|
Evaluation of the automatic landmark detection (Performance)
Time Frame: The procedure (day 0)
|
The relative ratio of the automatically identified landmarks by OTOPLAN that were not manually adjusted by the surgeon. The intended landmarks are:
|
The procedure (day 0)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
September 3, 2020
Study Completion (Anticipated)
November 4, 2020
Study Registration Dates
First Submitted
September 22, 2019
First Submitted That Met QC Criteria
September 22, 2019
First Posted (Actual)
September 25, 2019
Study Record Updates
Last Update Posted (Actual)
October 6, 2020
Last Update Submitted That Met QC Criteria
October 4, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000523
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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