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

Part of paid clinical trials in Miami, Florida.

Sponsor
Restorear Devices LLC
Study ID
NCT06375278
Status
Recruiting
Apply to this trial

Conditions

  • Cochlear Implantation
  • Cochlear Implants
  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intra-Ear Canal Cooling Catheter — DEVICE
    Mild therapeutic hypothermia will be applied via the catheter device installed inside the ear canal by an experienced surgeon during cochlear implantation (CI) surgery.

Study Details

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).

Key Dates

Start date
Sep 23, 2024
Status verified
Nov 2024
Primary completion
Apr 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Safety Study
    Aim 1: Ascertain the safety of the system and device in patients undergoing cochlear implantation (CI). Mild therapeutic hypothermia will be delivered to the subjects during CI surgery via the ear canal.
  • Experimental: Efficacy Study Cooling
    Aim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive mild therapeutic hypothermia via the ear canal during cochlear implant surgery.
  • No Intervention: Efficacy Study Control
    Aim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive standard of care (no cooling) during cochlear implant surgery.

Primary Outcome Measure

Pure Tone Audiometry [ Time Frame: At initial cochlear implant activation or 1 month post-operatively; 3 and 12 months post-operatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Suhrud M Rajguru, Ph.D.
[email protected]
8016418180
Sandra Prentiss, Ph.D., CCC-A
[email protected]
305-890-6059
Suhrud M Rajguru, Ph.D.
Michael Hoffer, M.D.
Fred Telischi, M.D.
Simon Angeli, M.D.
Sandra Prentiss, Ph.D.

Find similar trials in Miami, FL

By research site
University of Miami· Miami, FL

Related Studies