NCT04102215

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

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 1, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2020

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

September 22, 2019

Last Update Submit

October 4, 2020

Conditions

Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Electrode array insertion depth (Efficacy)

    The procedure (day 0)

  • Number of correctlly inserted electrode contact (Efficacy)

    The procedure (day 0)

  • Insertion depth prediction accuracy (Efficacy)

    The procedure (day 0)

  • Absolute angular accuracy of the drilled tunnel access

    The procedure (day 0)

  • Absolute lateral drilling accuracy of the drilled tunnel at the level of facial recess (Safety)

    The procedure (day 0)

  • +2 more secondary outcomes

Study Arms (1)

ARCI25

EXPERIMENTAL

Robot assited Cochlear implant surgery.

Device: HEARODevice: OTOPLAN

Interventions

HEARODEVICE

Robotic system for otological procedures

Also known as: HEARO procedures
ARCI25
OTOPLANDEVICE

Otological surgical planning software

ARCI25

Eligibility Criteria

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

You may qualify if:

  • Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Antwerp, Belgium

RECRUITING

Related Publications (2)

  • Heuninck E, Van de Heyning P, Van Rompaey V, Mertens G, Topsakal V. Audiological outcomes of robot-assisted cochlear implant surgery. Eur Arch Otorhinolaryngol. 2023 Oct;280(10):4433-4444. doi: 10.1007/s00405-023-07961-7. Epub 2023 Apr 12.

    PMID: 37043021DERIVED

  • 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

Central Study Contacts

Vedat Topsokal, Prof

CONTACT

003238213245vedat.topsakal@uza.be

Paul Van de Heyning, Prof

CONTACT

003238213245Paul.VandeHeyning@uza.be

Study Design

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

Study Record Dates

First Submitted

September 22, 2019

First Posted

September 25, 2019

Study Start

September 1, 2019

Primary Completion

September 3, 2020

Study Completion

November 4, 2020

Last Updated

October 6, 2020

Record last verified: 2020-10

Locations

BE(1)