NCT04795986

Brief Summary

To demonstrate the efficacy of a minimally invasive direct cochlear access via the HEARO procedure in cochlear implantation.

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
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

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

First Submitted

Initial submission to the registry

February 22, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 17, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

February 22, 2021

Last Update Submit

September 25, 2021

Conditions

Deafness

Keywords

cochlear implantationrobotic surgeryautomated inner ear accessautomated middle ear access

Outcome Measures

Primary Outcomes (1)

  • efficacy of cochlear access

    Percentage of patients with successful cochlear access with the hearo procedure (successful meaning no conventional mastoidectomy and posterior tympanotomy necessary)

    at implantation

Secondary Outcomes (2)

  • electrode array insertion outcomes

    at implantation

  • Safety of cochlear access

    at implantation

Interventions

HEARO ProcedurePROCEDURE

robotic access to the middle and inner ear in cochlear implantation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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
  • Pregnant women
  • Facial recess size does not allow a minimum distance of 0.4mm from the planned trajectory to the facial nerve and 0.3mm to the chorda tympani
  • Vulnerable or mentally retarded candidates
  • Invalid or withdrawn informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HNO Klinik am AKH Wien

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kliniksekretariat HNO Klinik

CONTACT

+43 1 40400 33760klinsek@push-email.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.-Prof. Priv.-Doz. Dr.

Study Record Dates

First Submitted

February 22, 2021

First Posted

March 12, 2021

Study Start

September 17, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)