Clinical Trial

Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation

Recruiting
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Summary
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are: 1. Is mild therapeutic hypothermia safe for use during cochlear implantation? 2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation? Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy).
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-04-30 -> 2027-03-31 2026-07-24
minor Completion pushed: 2026-07-31 -> 2027-09-30 2026-07-24
Trial Details
NCT Number NCT06375278
Lead Sponsor Restorear Devices LLC
Collaborators: University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions Cochlear Implants, Cochlear Implantation, Hearing Loss
Enrollment 54 participants
Start Date 2024-09-23
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-23