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

29 aprile 2026 aggiornato da: Marc Abreu

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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Florida
      • Aventura, Florida, Stati Uniti, 33160
        • BTT Medical Institute LLC

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

      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 contraindication for hyperthermia
      5. Clinically significant ECG 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Single Arm with one hyperthermia treatment
one hyperthermia treatment
Altro: Hyperthermia
controlled induced hyperthermia

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Lasso di tempo: 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
Baseline (pre-treatment) through post-treatment (48-hours post treatment)
Change in Cardiovascular Vital Signs (Heart Rate)
Lasso di tempo: 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
Baseline (pre-treatment) through post-treatment (48-hours post treatment)
Change in Cardiovascular Vital Signs (Blood Pressure)
Lasso di tempo: 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
Baseline (pre-treatment) through post-treatment (48-hours post treatment)]
Change in Comprehensive Metabolic Panel Renal Function Markers (Creatinine)
Lasso di tempo: 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)
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
Change in Comprehensive Metabolic Panel Renal Function (BUN)
Lasso di tempo: 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)
Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
Change in Comprehensive Metabolic Panel Renal Function (eGFR)
Lasso di tempo: 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)
Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
Change in Comprehensive Metabolic Panel Hepatic Function (AST)
Lasso di tempo: 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)
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
Change in Comprehensive Metabolic Panel Hepatic Function (ALT)
Lasso di tempo: 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)
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
Change in Comprehensive Metabolic Panel Hepatic Function (ALP)
Lasso di tempo: 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)
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
Change in Comprehensive Metabolic Panel Hepatic Function (Total Bilirubin)
Lasso di tempo: 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)
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
Change in Comprehensive Metabolic Panel Hepatic Function (GGT)
Lasso di tempo: 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)
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
Change in Hematologic Parameters (CBC- White Blood Cell Count)
Lasso di tempo: 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
Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
Change in Hematologic Parameters (CBC- Hemoglobin)
Lasso di tempo: 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
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
Change in Hematologic Parameters (CBC- Hematocrit)
Lasso di tempo: 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
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
Change in Hematologic Parameters (CBC- Platelet Count)
Lasso di tempo: 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
Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
Change in Hematologic Parameters (CBC- Erythrocyte Sedimentation Rate)
Lasso di tempo: 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
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
Change in Hematologic Parameters (C-Reactive Protein)
Lasso di tempo: 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
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Respiratory Parameters (Respiratory Rate)
Lasso di tempo: 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
Pretreatment through 48hrs. after the treatment
Change in Respiratory Parameters (Oxygen Saturation)
Lasso di tempo: 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
Pretreatment through 48hrs. after the treatment
Change in Pulmonary Function (FEV1)
Lasso di tempo: Pretreatment and 48hrs. after the treatment
  • Description: Change from baseline in pulmonary performance.
  • Unit of Measure: Standard spirometry parameters FEV1 (liters)
  • Measurement Tool: Spirometer
Pretreatment and 48hrs. after the treatment
Change in Pulmonary Function (FVC)
Lasso di tempo: Pretreatment and 48hrs. after the treatment
Change from baseline in pulmonary performance. Unit of Measure: Standard spirometry parameters FVC (liters) Measurement Tool: Spirometer
Pretreatment and 48hrs. after the treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Marc Abreu

Investigatori

  • Investigatore principale: Marcio Abreu, MD, BTT Medical Institute

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

17 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BTT 25-001 SS

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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