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NCT07564440

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

Enrolling by Invitation
NAAges 18–65InterventionalTreatment
Marc Abreu
~20 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Hyperthermia

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over Baseline (pre-treatment) through post-treatment (48-hours post treatment)
+16 more outcomes measured

Conditions

Safety Study

Explore related trials

Hyperthermia

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Marcio Abreu, MD · PRINCIPAL_INVESTIGATOR · BTT Medical Institute

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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

  • Change in Cardiovascular Vital Signs (Heart Rate)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

  • Change in Cardiovascular Vital Signs (Blood Pressure)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

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

  • Change in Comprehensive Metabolic Panel Renal Function (BUN)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)

  • Change in Comprehensive Metabolic Panel Renal Function (eGFR)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)

  • Change in Comprehensive Metabolic Panel Hepatic Function (AST)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)

  • Change in Comprehensive Metabolic Panel Hepatic Function (ALT)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)

  • Change in Comprehensive Metabolic Panel Hepatic Function (ALP)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)

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

  • Change in Comprehensive Metabolic Panel Hepatic Function (GGT)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)

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

  • Change in Hematologic Parameters (CBC- Hemoglobin)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

  • Change in Hematologic Parameters (CBC- Hematocrit)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

  • Change in Hematologic Parameters (CBC- Platelet Count)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

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

  • Change in Hematologic Parameters (C-Reactive Protein)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