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ENROLLING BY INVITATION

NCT07564440

Hyperthermia Safety Study Uses Temperature Management System to Gently Raise Participant's Body Temperature to a Fever-range Level in a Controlled Setting.

Sponsor: Marc Abreu

View on ClinicalTrials.gov

Summary

The Abreu BTT 700 Temperature Management System (TMS) is a device that gently raises the body temperature of the participant to a fever-range level in a controlled setting. There will be one study treatment session. with the TMS system and four safety assessments: before the session, about two hours afterward, on the next day, and again on the third day after the session. Your participation in the study will last about three days in total. An electrocardiogram (ECG - traces the electrical activity of the heart) will be performed during screening. This is not a randomized or blinded study -- all participants will receive the same study treatment. The TMS system has been previously used in other settings, but this study is designed specifically to collect safety data in adult volunteers.

Official title: Clinical and Biological Safety Study of the BTT Hyperthermia in Adult Subjects

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-05

Completion Date

2026-12

Last Updated

2026-05-04

Healthy Volunteers

Yes

Conditions

Safety Study

Interventions

OTHER

Hyperthermia

controlled induced hyperthermia

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

Locations (1)

BTT Medical Institute LLC

Aventura, Florida, United States