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NCT06375278 · ClinicalTrials.gov registry record · NA
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
A NA study of Hearing Loss and Cochlear Implantation, sponsored by Restorear Devices.
- Recruiting
- Registry status
- NA
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT06375278 is a NA study of Hearing Loss and Cochlear Implantation that is actively recruiting participants, run by Restorear Devices. The registered enrollment target is 54 participants, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06375278, a NA study of Hearing Loss and Cochlear Implantation, is actively recruiting participants, sponsored by Restorear Devices.
- RECRUITING
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study 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).
Conditions Studied
Interventions
- DEVICE Intra-Ear Canal Cooling Catheter
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2024-09-23 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06375278
The ClinicalTrials.gov registry entry for NCT06375278 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower). The listed sponsor is Restorear Devices, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Hearing Loss appearing as the primary indexed condition, and to 1 intervention - of which Intra-Ear Canal Cooling Catheter is the first listed.
NCT06375278 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06375278 about?
NCT06375278 is a clinical study titled "Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation". 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...
What is the current status of trial NCT06375278?
This trial is currently recruiting. It is a NA study. The enrollment target is 54 participants. The study started on 2024-09-23. Estimated completion is 2026-07-31.
What conditions does trial NCT06375278 study?
This clinical trial studies the following conditions: Hearing Loss, Cochlear Implantation, Cochlear Implants.
What interventions are being tested in trial NCT06375278?
The interventions under investigation include: Intra-Ear Canal Cooling Catheter (DEVICE).
Who is sponsoring clinical trial NCT06375278?
This trial is sponsored by Restorear Devices, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06375278 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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