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

Sensorineural Hearing Loss Clinical Trial

— ARCI25  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04102215
• Other study ID #: 000523
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: November 4, 2020

Study information

• Verified date: October 2020
• Source: University Hospital, Antwerp
• Contact: Vedat Topsokal, Prof
• Phone: 003238213245
• Email: vedat.topsakal[@]uza.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: November 4, 2020
• Est. primary completion date: September 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• Invalid or withdrawn informed consent

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Device:
• HEARO
Robotic system for otological procedures
• OTOPLAN
Otological surgical planning software

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Vedat Topsakal

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (%).	Image data aquired during the procedure
Secondary	Electrode array insertion depth (Efficacy)	The electrode insertion depth will be measured in the post-operative image. (Degrees °)	The procedure (day 0)
Secondary	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)	The procedure (day 0)
Secondary	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 °)	The procedure (day 0)
Secondary	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.	The procedure (day 0)
Secondary	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)	The procedure (day 0)
Secondary	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)	The procedure (day 0)
Secondary	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)	The procedure (day 0)