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Fever machine: could controlled heat be a new therapy?

NCT ID NCT07564440

Knowledge-focused Sponsor: Marc Abreu 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 21, 2026 · Updated 2 times

Summary

This study tests the safety of a device called the Abreu BTT 700, which gently raises a person's body temperature to a fever-like level. Twenty healthy adults aged 18 to 65 will receive one session of this controlled hyperthermia. Researchers will monitor for side effects and changes in vital signs and blood tests over three days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
controlled induced hyperthermia (device-based)
What this could lead to
If safe, this could pave the way for using controlled fever-range temperature as a therapy for various conditions.
What could go wrong
This is a very small, early safety study with only 20 healthy volunteers. It is not designed to test effectiveness, and the approach may not prove safe or useful for treating diseases.

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 20 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: \- A person who meets all of the following criteria will be eligible for this study: * Provision of signed and dated informed consent/assent form. * Ability to understand the nature of the study and protocol requirements and provide written informed consent. * Willingness to comply with all study procedures and availability for the duration of the study. * Aged over 18 years and no more than 65 years * Males and Female * Values of vital signs before BTT Hyperthermic Induction should be: * Systolic between 100-140 mm Hg o diastolic between 50-90 mm Hg * cardiac pulse between 45-90 beats per minute * Free from any treatment in the 7 days preceding inclusion including no use of analgesics or anti-inflammatory drugs) Exclusion Criteria: * History of Cardiovascular and venous thrombosis disorders * History of auto-immune disorders * History of pulmonary disease * History of Neurological disorders * History of Cancer disorders * Renal or Hepatic insufficiency * Medical history and / or surgical judged by the investigator or his representative as being incompatible with the test, especially subjects who do not support high fever range in the past during adult or childhood life. * Pathology evolutionary time of the review of inclusion * Excessive consumption of alcohol, tobacco (over 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug abuse. * The person(s) with the following condition(s) are excluded to participate in the study 1. Implanted electronic devices 2. Any metal implant 3. Dermatological conditions sensitive to heat 4. Any enclosed infection that, as assessed by a qualified physician, serves as a contraindication for hyperthermia 5. Clinically significant ECG findings, as per determined by a cardiologist, including uncontrolled arrhythmia 6. A subject who in the opinion of the Principal Investigator would not be able to safely complete the study

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Conditions

The condition(s) this trial relates to.

Hyperthermia

As listed by the trial registrant

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

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

  • BTT Medical Institute LLC

    Aventura, Florida, 33160, United States

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