AzTrials
AzTrials

Safety StudyBTTNCT07564440

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

A study testing Hyperthermia in people with Safety Study, run by Marc Abreu at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Safety Study
What is being tested?
Hyperthermia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Sep 2026to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • BTT Medical Institute LLC

    Aventura, Florida, 33160

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Conditions
Safety Study
Being tested
Hyperthermia
Keywords
Hyperthermia, induced fever
Medical subject headings
Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HyperthermiaOther

    controlled induced hyperthermia

Study groups in NCT07564440
Study groupRoleWhat they receive
Single Arm with one hyperthermia treatmentExperimentalone hyperthermia treatment
Receives: Other: Hyperthermia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

  3. 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

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

  4. 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)

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

  5. 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)

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

  6. 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)

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

  7. 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)

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

  8. 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)

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

  9. 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)

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

  10. 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)

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

  11. 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)

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

  12. 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

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

  13. 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

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

  14. 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

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

  15. 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

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

  16. 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

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

  17. 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

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

Secondary outcomes (4)

  1. Change in Respiratory Parameters (Respiratory Rate)

    • 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

    Measured: Pretreatment through 48hrs. after the treatment

  2. Change in Respiratory Parameters (Oxygen Saturation)

    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

    Measured: Pretreatment through 48hrs. after the treatment

  3. Change in Pulmonary Function (FEV1)

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

    Measured: Pretreatment and 48hrs. after the treatment

  4. Change in Pulmonary Function (FVC)

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

    Measured: Pretreatment and 48hrs. after the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07564440
Sponsor's protocol ID
BTT 25-001 SS
Acronym
BTT
Status last verified
Sep 2026
First submitted
17 Apr 2026
Last updated
21 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Oehler R, Pusch E, Zellner M, Dungel P, Hergovics N, Homoncik M, Eliasen MM, Brabec M, Roth E. Cell type-specific variations in the induction of hsp70 in human leukocytes by feverlike whole body hyperthermia. Cell Stress Chaperones. 2001 Oct;6(4):306-15. doi: 10.1379/1466-1268(2001)0062.0.co;2.

    PubMed 11795467

  • Brazaitis M, Eimantas N, Baranauskiene N, Kilikeviciene S, Vitkauskiene A, Daniuseviciute L. Effects of severe whole-body hyperthermia on ovarian hormone and extracellular Hsp72 responses in young adult women. Int J Hyperthermia. 2019;36(1):660-665. doi: 10.1080/02656736.2019.1627431.

    PubMed 31317816

  • Evans SS, Repasky EA, Fisher DT. Fever and the thermal regulation of immunity: the immune system feels the heat. Nat Rev Immunol. 2015 Jun;15(6):335-49. doi: 10.1038/nri3843. Epub 2015 May 15.

    PubMed 25976513

  • Zauner D, Quehenberger F, Hermann J, Dejaco C, Stradner MH, Stojakovic T, Angerer H, Rinner B, Graninger WB. Whole body hyperthermia treatment increases interleukin 10 and toll-like receptor 4 expression in patients with ankylosing spondylitis: a pilot study. Int J Hyperthermia. 2014 Sep;30(6):393-401. doi: 10.3109/02656736.2014.956810.

    PubMed 25256892

  • Mason AE, Chowdhary A, Hartogensis W, Siwik CJ, Lupesko-Persky O, Pandya LS, Roberts S, Anglo C, Moran PJ, Nelson JC, Lowry CA, Patrick RP, Raison CL, Hecht FM. Feasibility and acceptability of an integrated mind-body intervention for depression: whole-body hyperthermia (WBH) and cognitive behavioral therapy (CBT). Int J Hyperthermia. 2024;41(1):2351459. doi: 10.1080/02656736.2024.2351459. Epub 2024 May 14.

    PubMed 38743265

  • Mason AE, Hartogensis W, Chowdhary A, Siwik CJ, Pandya LS, Jung E, Lupesko-Persky O, Hartley E, Hopkins L, Roberts S, Borovinsky J, Nelson JC, Lowry CA, Patrick RP, Moran PJ, Raison CL, Hecht FM. A Randomized Trial Testing a Novel Mind and Body Intervention for Depression: Cognitive Behavioral Therapy (CBT) and Whole-Body Hyperthermia (WBH). Glob Adv Integr Med Health. 2025 Oct 22;14:27536130251387714. doi: 10.1177/27536130251387714. eCollection 2025 Jan-Dec.

    PubMed 41146956

  • Hanusch KU, Janssen CW. The impact of whole-body hyperthermia interventions on mood and depression - are we ready for recommendations for clinical application? Int J Hyperthermia. 2019;36(1):573-581. doi: 10.1080/02656736.2019.1612103.

    PubMed 31159624

  • https://clinicaltrials.gov/ct2/show/NCT03906149?term=Depression&cond=Hyperthermia&cntry=DE&city=Essen&rank=1 Whole-body Hyperthermia for Moderate to Severe Depressive Disorder (HYPE2)

  • https://classic.clinicaltrials.gov/ct2/show/NCT05366270?term=simmie+foster&cond=Depression&cntry=US&draw=2&rank=1 Massachusetts General Hospital Boston / USA Peripheral Neuroimmune Mechanisms of Hyperthermia

  • https://clinicaltrials.gov/ct2/show/NCT05821166 Charite University Berlin, Department of Radiation Oncology and Radiotherapy Potential of Moderate Whole Body Hyperthermia to Enhance Response (POWER)

  • Knobel A, Hanusch K, Auen N, Rübener F, Fischer S, Borzim C, Heinz A, Schäfer M: Whole-Body Hyperthermia (WBH) in Psychiatry In: Water-filtered Infrared A (wIRA) Irradiation (Ed.: P. Vaupel), pp. 155-164. Springer Nature Switzerland, Cham. DOI: 10.1007/978-3-030-92880-3_12 OPEN ACCESS https://link.springer.com/content/pdf/10.1007%2F978-3-030-92880-3_12

  • Naumann J, Grebe J, Kaifel S, Weinert T, Sadaghiani C, Huber R. Effects of hyperthermic baths on depression, sleep and heart rate variability in patients with depressive disorder: a randomized clinical pilot trial. BMC Complement Altern Med. 2017 Mar 28;17(1):172. doi: 10.1186/s12906-017-1676-5.

    PubMed 28351399

  • Flux MC, Smith DG, Allen JJB, Mehl MR, Medrano A, Begay TK, Middlemist BH, Marquart BM, Cole SP, Sauder CJ, Lowry CA, Raison CL. Association of plasma cytokines and antidepressant response following mild-intensity whole-body hyperthermia in major depressive disorder. Transl Psychiatry. 2023 Apr 21;13(1):132. doi: 10.1038/s41398-023-02402-9.

    PubMed 37085494

  • Brancato L, Gorbaslieva I, Rudenko O, Logghe T, van Zwol E, Boulet G, Van den Bossche L, Van den Bossche J, Peeters M, Chapelle T, Saldien V, Vueghs P, Vandamme T, Dankerlui R, Ysebaert D, Bogers J. The MATTERS Trial: Safety and Tolerability of Whole-Body Hyperthermia at 41.50 degrees C in Combination with Chemotherapy in Metastatic Cancer Patients. Cancer Res Commun. 2026 Feb 1;6(2):273-283. doi: 10.1158/2767-9764.CRC-25-0660.

    PubMed 41642747

  • Broomand MA, Kalantari Khandani M, Sandoughdaran S, Mirzaei H. Systemic Hyperthermia Combined with Chemotherapy: A Pilot Clinical Trial in the Treatment of Metastatic Gastrointestinal Cancers. Int J Cancer Manag. 2025;18(1):e159729. doi: https://doi.org/10.5812/ijcm-159729

Questions about this trial

What is this clinical trial studying?

A study testing Hyperthermia in people with Safety Study, run by Marc Abreu at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline (pre-treatment) through post-treatment (48-hours post treatment)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07564440, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in