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

Not Applicable

Completed

• Conditions: Sensorineural Hearing Loss
• Interventions: Device: HEARO

• Registration Number: NCT03746613
• Lead Sponsor: Prof. Vedat Topsakal

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.

Study Timeline

• Study Start: 2018-09-24
• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-19
• Primary Completion: 2019-04-27
• Study Completion: 2019-06-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minimally invasive robotic cochlear implantation with HEARO	HEARO	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Antwerp, Belgium