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

NCT07564440 | Enrolling By Invitation

• 1 other identifier: BTT 25-001 SS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Safety Study

Keywords

Hyperthermia; induced fever

Outcome Measures

Primary Outcomes (17)

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Incidence, type, and severity of treatment-emergent adverse events following whole-body hyperthermia (WBH). * Unit of Measure: Number and percentage of participants (%) * Measurement Tool: AE/SAE reporting using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and MedDRA coding

  Baseline (pre-treatment) through post-treatment (48-hours post treatment)

• Change in Cardiovascular Vital Signs (Heart Rate)

  * Change from baseline in heart rate. * Parameters: * Heart rate (beats per minute) * Unit of Measure: Absolute values and change from baseline * Measurement Tool: Automated vital signs monitor

  Baseline (pre-treatment) through post-treatment (48-hours post treatment)

• Change in Cardiovascular Vital Signs (Blood Pressure)

  Change from baseline in blood pressure. Parameters: Systolic/diastolic blood pressure (mmHg) Unit of Measure: Absolute values and change from baseline Measurement Tool: Automated vital signs monitor

  Baseline (pre-treatment) through post-treatment (48-hours post treatment)]

• Change in Comprehensive Metabolic Panel Renal Function Markers (Creatinine)

  * Change from baseline in renal function markers Creatinine * Parameters: * Renal: Creatinine (mg/dL) * Unit of Measure: Absolute values and change from baseline * Measurement Tool: Clinical chemistry analyzer (Comprehensive Metabolic Panel)

  Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)

• Change in Comprehensive Metabolic Panel Renal Function (BUN)

  * Change from baseline in renal function markers BUN * Parameters: * BUN (mg/dL) * Unit of Measure: Absolute values and change from baseline * Measurement Tool: Clinical chemistry analyzer (Comprehensive Metabolic Panel)

  Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)

• Change in Comprehensive Metabolic Panel Renal Function (eGFR)

  Change from baseline in renal function markers. (eGFR) * Parameters: eGFR (mL/min/1.73m²) Unit of Measure: Absolute values and change from baseline * Measurement Tool: Clinical chemistry analyzer (Comprehensive Metabolic Panel)

  Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)

• Change in Comprehensive Metabolic Panel Hepatic Function (AST)

  Change from baseline in Hepatic function markers. (AST) * Parameters: AST (U/L) Unit of Measure: Absolute values and change from baseline * Measurement Tool: Clinical chemistry analyzer (Comprehensive Metabolic Panel)

  Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)

• Change in Comprehensive Metabolic Panel Hepatic Function (ALT)

  Change from baseline in Hepatic function markers. (ALT) * Parameters: AST (U/L) Unit of Measure: Absolute values and change from baseline * Measurement Tool: Clinical chemistry analyzer (Comprehensive Metabolic Panel)

  Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)

• Change in Comprehensive Metabolic Panel Hepatic Function (ALP)

  Change from baseline in Hepatic function markers. (ALP) * Parameters: ALP (U/L) Unit of Measure: Absolute values and change from baseline * Measurement Tool: Clinical chemistry analyzer (Comprehensive Metabolic Panel)

  Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)

• Change in Comprehensive Metabolic Panel Hepatic Function (Total Bilirubin)

  Change from baseline in Hepatic function markers. (Total Bilirubin) * Parameters: Total Bilirubin (mg/dL) Unit of Measure: Absolute values and change from baseline * Measurement Tool: Clinical chemistry analyzer (Comprehensive Metabolic Panel)

  Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)

• Change in Comprehensive Metabolic Panel Hepatic Function (GGT)

  Change from baseline in Hepatic function markers. (GGT) • Parameters: GGT (U/L) Unit of Measure: Absolute values and change from baseline • Measurement Tool: Clinical chemistry analyzer (Comprehensive Metabolic Panel)

  Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)

• Change in Hematologic Parameters (CBC- White Blood Cell Count)

  * Change from baseline in hematologic indices. * Parameters: White Blood Cell Count * Unit of Measure: Standard laboratory units (thousand cells/µL) * Measurement Tool: Automated hematology analyzer

  Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)

• Change in Hematologic Parameters (CBC- Hemoglobin)

  Change in Hematologic Parameters (CBC- Hemoglobin) Change from baseline in hematologic indices. * Parameters: Hemoglobin * Unit of Measure: Standard laboratory units (g/dL) * Measurement Tool: Automated hematology analyzer

  Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)

• Change in Hematologic Parameters (CBC- Hematocrit)

  Change from baseline in hematologic indices. * Parameters: Hematocrit * Unit of Measure: Standard laboratory units (%) * Measurement Tool: Automated hematology analyzer

  Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)

• Change in Hematologic Parameters (CBC- Platelet Count)

  Change from baseline in hematologic indices. * Parameters: Platelet count * Unit of Measure: Standard laboratory units (thousand/uL ) * Measurement Tool: Automated hematology analyzer

  Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)

• Change in Hematologic Parameters (CBC- Erythrocyte Sedimentation Rate)

  * Change from baseline in hematologic indices. * Parameters: Erythrocyte Sedimentation Rate (ESR) * Unit of Measure: Standard laboratory units (mm/hr) • Measurement Tool: Automated hematology analyzer

  Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)

• Change in Hematologic Parameters (C-Reactive Protein)

  * Change from baseline in hematologic indices. * Parameters: C-Reactive Protein (CRP) * Unit of Measure: Standard laboratory units (mg/L) * Measurement Tool: Automated hematology analyzer

  Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)

Secondary Outcomes (4)

• Change in Respiratory Parameters (Respiratory Rate)

  Pretreatment through 48hrs. after the treatment

• Change in Respiratory Parameters (Oxygen Saturation)

  Pretreatment through 48hrs. after the treatment

• Change in Pulmonary Function (FEV1)

  Pretreatment and 48hrs. after the treatment

• Change in Pulmonary Function (FVC)

  Pretreatment and 48hrs. after the treatment

Study Arms (1)

Single Arm with one hyperthermia treatment

EXPERIMENTAL

one hyperthermia treatment

Other: Hyperthermia

Interventions

Hyperthermia OTHER

controlled induced hyperthermia

Single Arm with one hyperthermia treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.
• 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
• Implanted electronic devices
• Any metal implant
• Dermatological conditions sensitive to heat
• Any enclosed infection that, as assessed by a qualified physician, serves as a contraindication for hyperthermia
• Clinically significant ECG findings, as per determined by a cardiologist, including uncontrolled arrhythmia
• A subject who in the opinion of the Principal Investigator would not be able to safely complete the study

Sponsors & Collaborators

• Marc Abreu: lead

Study Sites (1)

BTT Medical Institute LLC

Aventura, Florida, 33160, United States

Location

Related Publications (27)

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MeSH Terms

Conditions

Hyperthermia

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Marcio Abreu, MD

  BTT Medical Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)