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

Not Applicable

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

• Registration Number: NCT04102215
• Lead Sponsor: Prof. Vedat Topsakal

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2019-09-22
• Study First Submitted QC: 2019-09-22
• Study First Posted: 2019-09-25
• Primary Completion: 2020-09-03
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-04
• Last Update Posted: 2020-10-06
• Study Completion: 2020-11-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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• Invalid or withdrawn informed consent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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARCI25	OTOPLAN	Robot assited Cochlear implant surgery.
ARCI25	HEARO	Robot assited Cochlear implant surgery.

Primary Outcome Measures

Name	Time	Method
The relative ratio of the electrode array insertion into the cochlea through the drilled direct cochlea access with HEARO procedure. (Efficacy)	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 (%).

Secondary Outcome Measures

Name	Time	Method
Electrode array insertion depth (Efficacy)	The procedure (day 0)	The electrode insertion depth will be measured in the post-operative image. (Degrees °)
Absolute angular accuracy of the drilled tunnel access	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.
Number of correctlly inserted electrode contact (Efficacy)	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)
Insertion depth prediction accuracy (Efficacy)	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 °)
Absolute lateral drilling accuracy of the drilled tunnel at the level of facial recess (Safety)	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)
Absolute lateral drilling accuracy of the drilled tunnel at the target (Safety)	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)
Evaluation of the automatic landmark detection (Performance)	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)

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Antwerp, Belgium