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

Sensorineural Hearing Loss Clinical Trial

— EAR2OS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746613
• Other study ID #: B300201837507
• Status: Completed
• Phase: N/A
• Start date: September 24, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: June 1, 2019
• Est. primary completion date: April 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• HEARO
Robotic system for otological procedures

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