Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03746613
Other study ID # B300201837507
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT00023036 - Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts
Recruiting NCT05568329 - Appreciation for Music Processed by Hearing Aids N/A
Withdrawn NCT05061758 - A Trial of LY3056480 in Patients With SNLH Phase 2
Completed NCT01434446 - The Effect of Sound Stimulation on Hearing Ability N/A
Completed NCT03212924 - Listening Effort in Cochlear Implant Users N/A
Recruiting NCT06053190 - Effects of Clear Speech on Listening Effort and Memory in Sentence Processing N/A
Completed NCT03718975 - Quality Control of CE-Certified Phonak Hearing Aids - 2018_28 N/A
Completed NCT06025097 - Intra-Tympanic Steroid With PRP Combination in Sensorineural Hearing Loss and Tinnitus. Early Phase 1
Recruiting NCT04102215 - The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure N/A
Recruiting NCT04108598 - The SeaSHeL National Prospective Cohort Study
Active, not recruiting NCT04750642 - Cochlear Implant With Dexamethasone Eluting Electrode Array N/A
Completed NCT04120116 - FX-322 in Adults With Stable Sensorineural Hearing Loss Phase 2
Recruiting NCT06223724 - Status Telemetry for Cochlear Implantations
Completed NCT02005822 - Congenital Cytomegalovirus: Efficacy of Antiviral Treatment Phase 3
Suspended NCT02616172 - Autologous Bone Marrow Harvest and Transplant for Sensorineural Hearing Loss Phase 1/Phase 2
Completed NCT02259595 - Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC Phase 1
Unknown status NCT01902914 - Effectiveness of P02 Digital Hearing Aids Phase 1/Phase 2
Completed NCT00589511 - Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study N/A
Completed NCT03288753 - Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors N/A
Completed NCT04462198 - Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss Phase 1/Phase 2