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Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array

Recruitingn/aAges 18 Years - anyAllCochlear
NCT06936449 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation. * Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642). * Willing and able to provide written informed consent. Exclusion Criteria: * Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the Investigator. * Additional disabilities that may affect the subject's participation or safety during the clinical investigation. * Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator. * Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
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What it tests

  • CI632D
  • CI632
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Where

3 sites
Rocky Mountain Ear Center
Englewood, United States
University of Iowa
Iowa City, United States
University Hospitals Cleveland
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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