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Enrolling by Invitation

NCT Number: NCT07564440

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

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.

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Key information

Conditions

Safety Study Body Temperature Changes Heat Stress Disorders Hyperthermia Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BTT Medical Institute LLC

Aventura, Florida, 33160, United States

About this study

Participants are being asked to take part because they are healthy adults between the ages of 18 and 65 and have no history of any heart, cancer, or neurological disorders. Participation in this study will help researchers understand how healthy people respond to this technology before it is tested in people with specific medical conditions.

Voluntary Participation: Taking part in this study is completely voluntary. Volunteers do not have to participate and may withdraw at any time. Stopping to participate in the study will not result in any penalties or loss of benefits.

Benefits, Compensation, and Risk: Subjects may not receive any direct benefit from participating in this study. However, participation will help researchers develop safer treatments for others in the future. There is no cost to participate.

Possible risks include feeling tired, sweating, or experiencing temporary changes in heart rate or blood pressure. Rare but serious risks could include overheating, dehydration, or fainting. The study team will monitor you closely throughout the process to minimize risks and will stop the session immediately if there are any safety concerns.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Hyperthermia

Other

controlled induced hyperthermia

Primary outcomes

  1. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline (pre-treatment) through post-treatment (48-hours post treatment)

    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

  2. Change in Cardiovascular Vital Signs (Heart Rate)

    Time frame: Baseline (pre-treatment) through post-treatment (48-hours post treatment)

    • 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

  3. Change in Cardiovascular Vital Signs (Blood Pressure)

    Time frame: Baseline (pre-treatment) through post-treatment (48-hours post treatment)]

    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

  4. Change in Comprehensive Metabolic Panel Renal Function Markers (Creatinine)

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

    • 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)

  5. Change in Comprehensive Metabolic Panel Renal Function (BUN)

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

    • 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)

  6. Change in Comprehensive Metabolic Panel Renal Function (eGFR)

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

    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)

  7. Change in Comprehensive Metabolic Panel Hepatic Function (AST)

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

    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)

  8. Change in Comprehensive Metabolic Panel Hepatic Function (ALT)

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

    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)

  9. Change in Comprehensive Metabolic Panel Hepatic Function (ALP)

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

    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)

  10. Change in Comprehensive Metabolic Panel Hepatic Function (Total Bilirubin)

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

    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)

  11. Change in Comprehensive Metabolic Panel Hepatic Function (GGT)

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

    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)

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

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

    • 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

  13. Change in Hematologic Parameters (CBC- Hemoglobin)

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

    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

  14. Change in Hematologic Parameters (CBC- Hematocrit)

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

    Change from baseline in hematologic indices.

    • Parameters: Hematocrit
    • Unit of Measure: Standard laboratory units (%)
    • Measurement Tool: Automated hematology analyzer

  15. Change in Hematologic Parameters (CBC- Platelet Count)

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

    Change from baseline in hematologic indices.

    • Parameters: Platelet count
    • Unit of Measure: Standard laboratory units (thousand/uL )
    • Measurement Tool: Automated hematology analyzer

  16. Change in Hematologic Parameters (CBC- Erythrocyte Sedimentation Rate)

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

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

  17. Change in Hematologic Parameters (C-Reactive Protein)

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

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

Secondary outcomes

  1. Change in Respiratory Parameters (Respiratory Rate)

    Time frame: Pretreatment through 48hrs. after the treatment

    • Change from baseline in respiratory rate
    • Parameters:
    • Respiratory rate (breaths/min)
    • Unit of Measure: Absolute values and change from baseline
    • Measurement Tool: Pulse oximeter and respiratory monitor

  2. Change in Respiratory Parameters (Oxygen Saturation)

    Time frame: Pretreatment through 48hrs. after the treatment

    Change from baseline in oxygen Saturation.

    • Parameters: Oxygen saturation (%)
    • Unit of Measure: Absolute values and change from baseline
    • Measurement Tool: Pulse oximeter and respiratory monitor

  3. Change in Pulmonary Function (FEV1)

    Time frame: Pretreatment and 48hrs. after the treatment

    • Description: Change from baseline in pulmonary performance.
    • Unit of Measure: Standard spirometry parameters FEV1 (liters)
    • Measurement Tool: Spirometer

  4. Change in Pulmonary Function (FVC)

    Time frame: Pretreatment and 48hrs. after the treatment

    Change from baseline in pulmonary performance. Unit of Measure: Standard spirometry parameters FVC (liters) Measurement Tool: Spirometer

Sponsors and collaborators

Lead sponsor

Marc Abreu

Other

Registry information

Official study title

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

Acronym: BTT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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