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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Apr 30, 2026 → Mar 31, 2027
See other at-risk trials from Restorear Devices LLC

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Apr 30, 2026 to Mar 31, 2027
    • Study completion pushed from Jul 31, 2026 to Sep 30, 2027
    • Site contact updated
    v4
  2. Primary endpoints: 2 to 1v3 Show 4 more changesShow less
    • Interventions: Intra-Ear Canal Cooling Catheter (Device), Intra-Ear Canal Cooling Catheter (Sham) (Device) to Intra-Ear Canal Cooling Catheter (Device)
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Study arms: 2 to 3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date changed from estimate of Jun 1, 2024 to Sep 23, 2024
    • Primary completion date: Dec 31, 2025 to Apr 30, 2026
    • Study completion date: Mar 31, 2026 to Jul 31, 2026
    • Site details revised
    • Eligibility criteria expanded, about 5 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06375278
Lead Sponsor Restorear Devices LLC
Collaborators: University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions
(from sponsor)		 Cochlear Implants, Cochlear Implantation, Hearing Loss
Related terms Hearing Loss
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov