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Enrolling by invitationNCT07564440BTTUpdated Sep 21, 2026

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

An interventional study of Hyperthermia in Safety Study, sponsored by Marc Abreu. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Marc Abreu · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Safety Study

Browse trials for

Keywords

  • Hyperthermia
  • induced fever
03

In context

Hyperthermia

256 studies on the registry are indexed under Hyperthermia; 73 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 232 interventional studies indexed under Hyperthermia.

Browse Hyperthermia studies →

Lead sponsor

This is the only study on the registry with Marc Abreu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- A person who meets all of the following criteria will be eligible for this study:

  • Provision of signed and dated /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

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 for hyperthermia
      5. 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Single Arm with one hyperthermia treatment

    one hyperthermia treatment

    Other: Hyperthermia

Interventions

  • OtherHyperthermia

    controlled induced hyperthermia

06

What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Pretreatment and 48hrs. after the treatment

07

Study locations

1 site
  • BTT Medical Institute LLC
    Aventura, Florida 33160, United States
08

References and documents

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
  • Kobayashi Y, Ito Y, Ostapenko VV, Sakai M, Matsushita N, Imai K, Shimizu K, Aruga A, Tanigawa K. Fever-range whole-body heat treatment stimulates antigen-specific T-cell responses in humans. Immunol Lett. 2014 Nov;162(1 Pt A):256-61. doi: 10.1016/j.imlet.2014.09.014. Epub 2014 Sep 26. PubMed 25256774 ↗
  • Zschaeck S, Weingartner J, Ghadjar P, Wust P, Mehrhof F, Kalinauskaite G, Ehrhardt VH, Hartmann V, Tinhofer I, Heiland M, Coordes A, Kofla G, Budach V, Stromberger C, Beck M. Fever range whole body hyperthermia for re-irradiation of head and neck squamous cell carcinomas: Final results of a prospective study. Oral Oncol. 2021 May;116:105240. doi: 10.1016/j.oraloncology.2021.105240. Epub 2021 Feb 21. PubMed 33626457 ↗
  • Hohneck AL, Sadikaj L, Heinemann L, Schroeder M, Riess H, Gerhards A, Burkholder I, Heckel-Reusser S, Gottfried J, Hofheinz RD. Patients with Advanced Pancreatic Cancer Treated with Mistletoe and Hyperthermia in Addition to Palliative Chemotherapy: A Retrospective Single-Center Analysis. Cancers (Basel). 2023 Oct 11;15(20):4929. doi: 10.3390/cancers15204929. PubMed 37894296 ↗
  • Faghihi Moghaddam F, Bakhshandeh M, Mofid B, Sahinbas H, Faeghi F, Mirzaei H, Rakhsha A, Yousefi Kashi AS, Sadeghi R, Mahdavi A. Clinical effectiveness of combined whole body hyperthermia and external beam radiation therapy (EBRT) versus EBRT alone in patients with painful bony metastases: A phase III clinical trial study. J Therm Biol. 2024 Feb;120:103804. doi: 10.1016/j.jtherbio.2024.103804. Epub 2024 Feb 23. PubMed 38460451 ↗
  • Liu P, Wu J, Chen L, Wu Z, Wu Y, Zhang G, Yu B, Zhang B, Wei N, Shi J, Zhang C, Lei L, Yu S, Lai J, Guo Z, Zheng Y, Jing Z, Jiang H, Wang T, Zhou J, Wu Y, Sun C, Shen J, Zhang J, Wu Z. Water-filtered infrared A radiation hyperthermia combined with immunotherapy for advanced gastrointestinal tumours. Cancer Med. 2024 Jul;13(14):e70024. doi: 10.1002/cam4.70024. PubMed 39049187 ↗
  • Kockelmann F, Giger-Pabst U, Ouaissi M, Bucur P, Barbey S, VON Ardenne A, Zieren J. First Clinical Safety and Feasibility Data of Whole-body Hyperthermia Pressurized Intraperitoneal Aerosol Chemotherapy (WBH-PIPAC) for Peritoneal Surface Malignancies. Anticancer Res. 2024 Jul;44(7):3043-3050. doi: 10.21873/anticanres.17117. PubMed 38925817 ↗
  • Liebl CM, Kutschan S, Dorfler J, Kasmann L, Hubner J. Systematic review about complementary medical hyperthermia in oncology. Clin Exp Med. 2022 Nov;22(4):519-565. doi: 10.1007/s10238-022-00846-9. Epub 2022 Jun 29. PubMed 35767077 ↗
  • Mason AE, Fisher SM, Chowdhary A, Guvva E, Veasna D, Floyd E, Fender SB, Raison C. Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol. Int J Hyperthermia. 2021;38(1):1529-1535. doi: 10.1080/02656736.2021.1991010. PubMed 34674592 ↗
  • Vertree RA, Leeth A, Girouard M, Roach JD, Zwischenberger JB. Whole-body hyperthermia: a review of theory, design and application. Perfusion. 2002 Jul;17(4):279-90. doi: 10.1191/0267659102pf588oa. PubMed 12139385 ↗
  • Kraybill WG, Olenki T, Evans SS, Ostberg JR, O'Leary KA, Gibbs JF, Repasky EA. A phase I study of fever-range whole body hyperthermia (FR-WBH) in patients with advanced solid tumours: correlation with mouse models. Int J Hyperthermia. 2002 May-Jun;18(3):253-66. doi: 10.1080/02656730110116704. PubMed 12028640 ↗
  • Hohneck AL, Schmitz-Solheid V, Gencer D, Schroeder M, Riess H, Gerhards A, Burkholder I, Heckel-Reusser S, Gottfried J, Hofheinz RD. Predictors of Successful Whole-Body Hyperthermia in Cancer Patients: Target Temperature Achievement and Safety Analysis. Cancers (Basel). 2025 Aug 21;17(16):2716. doi: 10.3390/cancers17162716. PubMed 40867345 ↗
  • Smadja DM, Abreu MM. Hyperthermia and targeting heat shock proteins: innovative approaches for neurodegenerative disorders and Long COVID. Front Neurosci. 2025 Feb 4;19:1475376. doi: 10.3389/fnins.2025.1475376. eCollection 2025. PubMed 39967803 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.

Of 103 non-industry interventional studies with no phase under Hyperthermia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 6 months is below that.

Counting every sponsor, half of 108 studies reached it within 18 months; a quarter within 7 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2026
First posted
May 4, 2026
StartEst.
Sep 2026
Primary completionEst.
Mar 2027
CompletionEst.
Apr 2027
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07564440
Lead sponsor
Marc Abreu
Responsible party
Marc Abreu (Chief Medical Officer, BTT Medical Institute LLC) — Sponsor-investigator
First posted
May 4, 2026
Start date
Sep 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Marcio Abreu, MD
principal investigator · BTT Medical Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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