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New device aims to warm trauma patients faster, cutting deadly risks

NCT ID NCT06788925

Disease control Sponsor: ThermoTrauma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new heating device called Therm'Up to manage hypothermia in trauma patients. Hypothermia, when body temperature drops below 35°C, can worsen injuries and increase death risk. The trial will enroll 100 adults at risk of hypothermia due to trauma, cold exposure, or burns, and measure how well the device maintains or raises body temperature during prehospital care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years; Confi dential Page 7on 11 Version No. 2.0 of 2024/12/10 * Patient at risk of hypothermia presenting with grade A, or B, or C trauma or patient with hypothermia; * Patient exposed to cold; * Patient with hemorrhage; * Patient burned over 20% of body surface area; * Patient requiring an intervention delay of more than 30 minutes (between the arrival of the medical team on site and arrival at the hospital) Exclusion Criteria: * Patient with known ongoing hyperthermia and/or infections or body injuries such as burns in the area where the breastplate is positioned; * Patient presenting with cardiac arrest before the arrival of the team; * Patient with bilateral aural bleeding preventing continuous monitoring of the eardrum; * Patient covered with insulating bubble wrap; * Pregnant or breastfeeding woman; * Patient already participating in an interventional clinical trial; * Patient not receiving social security benefi ts; * Adult patient subject to a legal protection measure, guardianship or deprived of liberty by a judicial or administrative decision.

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Conditions

The condition(s) this trial relates to.

Hypothermia injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypothermia due to cold environment

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Grenoble Alpes University Hospital

    Échirolles, 38130, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.