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

Sponsor

Prof. Vedat Topsakal (Other)

Overall Status

Completed

CT.gov ID

NCT03746613

Collaborator

(none)

Enrollment

Location

Arm

8.2

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sensorineural Hearing Loss	Device: HEARO	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 24, 2018

Actual Primary Completion Date :

Apr 27, 2019

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Minimally invasive robotic cochlear implantation with HEARO	Device: HEARO Robotic system for otological procedures Other Names: HEARO procedure

Arm

Intervention/Treatment

Experimental: Minimally invasive robotic cochlear implantation with HEARO

Device: HEARO

Robotic system for otological procedures

Other Names:

HEARO procedure

Outcome Measures

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. [Image data aquired during the procedure]

Secondary Outcome Measures

Number of completed middle ear access [The procedure (day 0)]
Number of completed inner ear access [The procedure (day 0)]
Accuracy of the drilled trajectory [Image data aquired during the procedure]
Sensitivity and specificity of facial nerve monitoring [The procedure (day 0)]
Measurement of the insertion angle [Image data aquired during the procedure]
Measurement of the insertion depth of the electrode into the Cochlea
Number of tip fold-overs [The procedure (day 0)]
Number of Scala deviations [The procedure (day 0)]
Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection [day 0-30]
Time of procedure [The procedure (day 0)]
Volume of tissue removed [Image data aquired during the procedure]