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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: Recruiting NA study of Hearing Loss and Cochlear Implantation, sponsored by Restorear Devices.

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

Pure-tone average (PTA) of 125, 250 and 500 Hz which will be tested post-operatively in the safety and efficacy arms to measure residual hearing. A clinically significant change in hearing is greater than 10 dB HL (decibels hearing level) shift.

Conditions Studied

Hearing Loss Cochlear Implantation Cochlear Implants

Interventions

  • DEVICE Intra-Ear Canal Cooling Catheter

Study Locations (1)

Florida

  • University of Miami - Miami

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2024-09-23
Est. Completion 2026-07-31
Phase NA
Restorear Devices

4 total trials

What NCT06375278 shows while recruiting

NCT06375278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower).

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 a single indexed study location in 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

Similar trials for Hearing Loss

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06375278's enrollment target sits among peer trials

54 37th of 58 higher than 22 of 58 other Hearing Loss trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hearing Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06375278

Source: ClinicalTrials.gov NCT06375278, the US trial registry maintained by the National Library of Medicine. NCT06375278 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.