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

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

Study Contact Backup

Study Locations

      • Antwerp, Belgium
        • Recruiting
        • Antwerp University Hospital
        • Contact:
        • 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  • Invalid or withdrawn informed consent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:
  • HEARO procedures
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)

  • number of contacts inserted (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:

  • 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)
The procedure (day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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