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The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure (ARCI25)

Primary Purpose

Sensorineural Hearing Loss

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
HEARO
OTOPLAN
Sponsored by
Prof. Vedat Topsakal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensorineural Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Invalid or withdrawn informed consent

Sites / Locations

  • Antwerp University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARCI25

Arm Description

Robot assited Cochlear implant surgery.

Outcomes

Primary Outcome Measures

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 (%).

Secondary Outcome Measures

Electrode array insertion depth (Efficacy)
The electrode insertion depth will be measured in the post-operative image. (Degrees °)
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)
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 °)
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.
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)
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)
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)

Full Information

First Posted
September 22, 2019
Last Updated
October 4, 2020
Sponsor
Prof. Vedat Topsakal
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1. Study Identification

Unique Protocol Identification Number
NCT04102215
Brief Title
The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure
Acronym
ARCI25
Official Title
The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 3, 2020 (Actual)
Study Completion Date
November 4, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Vedat Topsakal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
SIngle arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARCI25
Arm Type
Experimental
Arm Description
Robot assited Cochlear implant surgery.
Intervention Type
Device
Intervention Name(s)
HEARO
Other Intervention Name(s)
HEARO procedures
Intervention Description
Robotic system for otological procedures
Intervention Type
Device
Intervention Name(s)
OTOPLAN
Intervention Description
Otological surgical planning software
Primary Outcome Measure Information:
Title
The relative ratio of the electrode array insertion into the cochlea through the drilled direct cochlea access with HEARO procedure. (Efficacy)
Description
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 (%).
Time Frame
Image data aquired during the procedure
Secondary Outcome Measure Information:
Title
Electrode array insertion depth (Efficacy)
Description
The electrode insertion depth will be measured in the post-operative image. (Degrees °)
Time Frame
The procedure (day 0)
Title
Number of correctlly inserted electrode contact (Efficacy)
Description
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)
Time Frame
The procedure (day 0)
Title
Insertion depth prediction accuracy (Efficacy)
Description
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 °)
Time Frame
The procedure (day 0)
Title
Absolute angular accuracy of the drilled tunnel access
Description
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.
Time Frame
The procedure (day 0)
Title
Absolute lateral drilling accuracy of the drilled tunnel at the level of facial recess (Safety)
Description
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)
Time Frame
The procedure (day 0)
Title
Absolute lateral drilling accuracy of the drilled tunnel at the target (Safety)
Description
The absolute lateral accuracy of the drilled tunnel is measured as the distance between the planned and actual target position. (mm)
Time Frame
The procedure (day 0)
Title
Evaluation of the automatic landmark detection (Performance)
Description
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)
Time Frame
The procedure (day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vedat Topsokal, Prof
Phone
003238213245
Email
vedat.topsakal@uza.be
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Van de Heyning, Prof
Phone
003238213245
Email
Paul.VandeHeyning@uza.be
Facility Information:
Facility Name
Antwerp University Hospital
City
Antwerp
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vedat Topsakal, Prof
Phone
003238213245
Email
vedat.topsakal@uza.be
First Name & Middle Initial & Last Name & Degree
Vedat Topsakal, Prof
First Name & Middle Initial & Last Name & Degree
Paul van de Heyning, Prof
First Name & Middle Initial & Last Name & Degree
Marco Matulic
First Name & Middle Initial & Last Name & Degree
Vincent Van Rompaey, Prof
First Name & Middle Initial & Last Name & Degree
Griet Mertens, Prof
First Name & Middle Initial & Last Name & Degree
Masoud Zoka Assadi, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35386404
Citation
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.
Results Reference
derived

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The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure

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