search
Back to results

Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques (EAR2OS)

Primary Purpose

Sensorineural Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
HEARO
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 focused on measuring robot, Image guidance, Cochlear implantation, navigation, HEARO procedure, sensorineural hearing loss, inner ear access

Eligibility Criteria

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

Inclusion Criteria:

  • Patients suffering from profound sensorineural deafness requiring a Cochlear implant

Exclusion Criteria:

  • Age under 18 years
  • Pregnant women
  • Anatomical anomalies of temporal bone
  • Chronic otitis media with or without cholesteatoma

Sites / Locations

  • Antwerp University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Minimally invasive robotic cochlear implantation with HEARO

Arm Description

Outcomes

Primary Outcome Measures

The relative ratio of successfully completed procedures where a direct access tunnel was drilled to the cochlea with the HEARO® system and the electrode was conventionally inserted through the tunnel.

Secondary Outcome Measures

Number of completed middle ear access
Number of completed inner ear access
Accuracy of the drilled trajectory
Sensitivity and specificity of facial nerve monitoring
Measurement of the insertion angle
Measurement of the insertion depth of the electrode into the Cochlea
Number of tip fold-overs
Number of Scala deviations
Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection
Time of procedure
Volume of tissue removed

Full Information

First Posted
November 12, 2018
Last Updated
July 23, 2019
Sponsor
Prof. Vedat Topsakal
search

1. Study Identification

Unique Protocol Identification Number
NCT03746613
Brief Title
Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
Acronym
EAR2OS
Official Title
Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
April 27, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

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 assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.
Detailed Description
Demonstrate the feasibility and efficacy of performing a middle and inner ear access for cochlear implantation procedures in adults. Validate the procedure workflow including imaging, planning, safety assessment, image to patient registration, robotic drilling, electrode insertion and device implantation. Validate the system and procedure safety mechanisms. Collect required data for validation of safety algorithms and procedure workflow optimisation. Validate the HEARO system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss
Keywords
robot, Image guidance, Cochlear implantation, navigation, HEARO procedure, sensorineural hearing loss, inner ear access

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimally invasive robotic cochlear implantation with HEARO
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
HEARO
Other Intervention Name(s)
HEARO procedure
Intervention Description
Robotic system for otological procedures
Primary Outcome Measure Information:
Title
The relative ratio of successfully completed procedures where a direct access tunnel was drilled to the cochlea with the HEARO® system and the electrode was conventionally inserted through the tunnel.
Time Frame
Image data aquired during the procedure
Secondary Outcome Measure Information:
Title
Number of completed middle ear access
Time Frame
The procedure (day 0)
Title
Number of completed inner ear access
Time Frame
The procedure (day 0)
Title
Accuracy of the drilled trajectory
Time Frame
Image data aquired during the procedure
Title
Sensitivity and specificity of facial nerve monitoring
Time Frame
The procedure (day 0)
Title
Measurement of the insertion angle
Description
Measurement of the insertion depth of the electrode into the Cochlea
Time Frame
Image data aquired during the procedure
Title
Number of tip fold-overs
Time Frame
The procedure (day 0)
Title
Number of Scala deviations
Time Frame
The procedure (day 0)
Title
Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection
Time Frame
day 0-30
Title
Time of procedure
Time Frame
The procedure (day 0)
Title
Volume of tissue removed
Time Frame
Image data aquired during the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suffering from profound sensorineural deafness requiring a Cochlear implant Exclusion Criteria: Age under 18 years Pregnant women Anatomical anomalies of temporal bone Chronic otitis media with or without cholesteatoma
Facility Information:
Facility Name
Antwerp University Hospital
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium

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

Learn more about this trial

Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques

We'll reach out to this number within 24 hrs