NCT07146841 Hearing Preservation in Cochlear Implantation Surgery
| NCT ID | NCT07146841 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Sensorineural Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2020-01-29 |
| Primary Completion | 2027-01-01 |
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 48 participants in total. It began in 2020-01-29 with a primary completion date of 2027-01-01.
⚠ 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
In order to preserve the residual hearing in patients with sensorineural hearing loss (SNHL) receiving a cochlear implant (CI), the insertion trauma to the delicate and microscopic structures of the cochlea needs to be minimized. The surgical procedure starts with the conventional mastoidectomy-posterior tympanotomy (MPT) approach to the middle ear, and is followed by accessing the cochlea, with either a cochleostomy (CO) or via the round window (RW). Both techniques have their benefits and disadvantages. Another aspect is the design of the electrode array. There are fundamentally two different designs: a \*straight\* lateral wall lying electrode array (LW), or a \*pre-curved\* perimodiolar cochlear lying electrode array (PM). Interestingly, until now, the best surgical approach and type of implant is unknown. Our hypothesis is that the combination of a RW approach and a LW lying electrode array minimizes insertion trauma, leading to better hearing outcome for SNHL patients.
Eligibility Criteria
Inclusion Criteria: * Severe hearing loss, CI candidate * 18 years of age or older * normal function of middle ear (i.e. no acute middle ear infections) * dutch language proficiency * choice for Advanced Bionics implant Exclusion Criteria: * prior otologic surgery in the implanted ear (excluding tympanostomy tube placement) * inner ear malformation present in the ear to be implanted (i.e. ossification, Mondini malformation) * retrocochlear pathology present in the auditory system to be implanted * neurocognitive disorders * sudden deafness
Contact & Investigator
Hans GXM Thomeer, MD, PhD
PRINCIPAL INVESTIGATOR
UMC Utrecht
Frequently Asked Questions
Who can join the NCT07146841 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sensorineural Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07146841 currently recruiting?
Yes, NCT07146841 is actively recruiting participants. Contact the research team at i.a.m.l.vanbeurden-5@umcutrecht.nl for enrollment information.
Where is the NCT07146841 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT07146841 clinical trial?
NCT07146841 is sponsored by UMC Utrecht. The principal investigator is Hans GXM Thomeer, MD, PhD at UMC Utrecht. The trial plans to enroll 48 participants.