NCT06453343

Brief Summary

This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up assessments). Participants will be randomized to one of two surgical approaches: eRW or CO, with a 1:1 allocation in a parallel design.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Jan 2025Nov 2027

First Submitted

Initial submission to the registry

April 29, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

April 29, 2024

Last Update Submit

February 21, 2025

Conditions

Cochlear ImplantsHearing Loss, Sensorineural

Keywords

Surgical approachRound WindowCochleostomyElectrocochleographyImagingResidual hearing preservation

Outcome Measures

Primary Outcomes (1)

  • Residual hearing

    The difference in residual hearing per group (eRW or CO) between pre- and postoperative pure tone thresholds, averaged at 500, 750 and 1000 Hz (PTAlow).

    3-months postoperatively

Secondary Outcomes (2)

  • ECochG thresholds after multiple surgery stages

    Intraoperatively

  • Intracochlear electrode position

    3-months postoperatively

Study Arms (2)

Cochleostomy

ACTIVE COMPARATOR

When employing the cochleostomy approach, a carefully positioned opening will be drilled anterior-inferior to the eRW membrane.

Procedure: Surgical approach: cochleostomy or extended round window

extended Round Window

ACTIVE COMPARATOR

In case of the extended round window approach, the scala tympani will be accessed through the extended round window technique, involving the creation of a round window margin cochleostomy.

Procedure: Surgical approach: cochleostomy or extended round window

Interventions

Surgical approach: cochleostomy or extended round windowPROCEDURE

Surgical placement of a cochlear implant electrode array

Cochleostomyextended Round Window

Eligibility Criteria

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

You may qualify if:

  • Individuals aged 18 years and older who have clinically established post-linguistic sensorineural hearing loss.
  • CI candidate based on local or national reimbursement criteria.
  • Cochlear implantation with a CI632.
  • Preoperative 500 Hz pure-tone air conduction threshold \<80 dB hearing level (HL) in the ear to be implanted.
  • Willing and able to provide written informed consent.

You may not qualify if:

  • Previous or existing CI recipient.
  • Ossification or other anatomical abnormalities of the cochlea or its windows possibly affecting normal electrode array insertion.
  • Abnormal cochlear nerve anatomy on preoperative CT or MRI.
  • Subjects who are unable to undergo CT or MRI.
  • Deafness due to acoustic nerve or central auditory pathway lesions.
  • Diagnosis of auditory neuropathy.
  • Active middle ear infection.
  • Additional handicaps that would prevent participation in study evaluations.
  • Unrealistic expectations from the participant regarding the possible benefits, risks, and limitations inherent to the CI procedure and the investigation.
  • Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, Netherlands

RECRUITING

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

Coby Lindeboom, MD

CONTACT

024 361 14934Coby.lindeboom@radboudumc.nl

Emmanuel Mylanus

CONTACT

Emmanuel.Mylanus@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2024

First Posted

June 11, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)