NCT03746613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

November 12, 2018

Last Update Submit

July 23, 2019

Conditions

Sensorineural Hearing Loss

Keywords

robotImage guidanceCochlear implantationnavigationHEARO proceduresensorineural hearing lossinner ear access

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

Minimally invasive robotic cochlear implantation with HEARO

EXPERIMENTAL
Device: HEARO

Interventions

HEARODEVICE

Robotic system for otological procedures

Also known as: HEARO procedure
Minimally invasive robotic cochlear implantation with HEARO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from profound sensorineural deafness requiring a Cochlear implant

You may not qualify if:

  • Age under 18 years
  • Pregnant women
  • Anatomical anomalies of temporal bone
  • Chronic otitis media with or without cholesteatoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Antwerp, 2650, Belgium

Location

Related Publications (1)

  • Topsakal V, Heuninck E, Matulic M, Tekin AM, Mertens G, Van Rompaey V, Galeazzi P, Zoka-Assadi M, van de Heyning P. First Study in Men Evaluating a Surgical Robotic Tool Providing Autonomous Inner Ear Access for Cochlear Implantation. Front Neurol. 2022 Mar 21;13:804507. doi: 10.3389/fneur.2022.804507. eCollection 2022.

    PMID: 35386404DERIVED

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2018

First Posted

November 19, 2018

Study Start

September 24, 2018

Primary Completion

April 27, 2019

Study Completion

June 1, 2019

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

BE(1)