NCT06453343 Clinical Trial to Compare Two Surgical Approaches to the Cochlea
| NCT ID | NCT06453343 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | Cochlear Implants |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 & Investigator
Frequently Asked Questions
Who can join the NCT06453343 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cochlear Implants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06453343 currently recruiting?
Yes, NCT06453343 is actively recruiting participants. Contact the research team at Coby.lindeboom@radboudumc.nl for enrollment information.
Where is the NCT06453343 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT06453343 clinical trial?
NCT06453343 is sponsored by Radboud University Medical Center. The trial plans to enroll 50 participants.