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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 kwietnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rejestracja na zaproszenie

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Florida
      • Aventura, Florida, Stany Zjednoczone, 33160
        • BTT Medical Institute LLC

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Single Arm with one hyperthermia treatment
one hyperthermia treatment
Inny: Hyperthermia
controlled induced hyperthermia

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Respiratory Parameters (Respiratory Rate)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Marc Abreu

Śledczy

  • Główny śledczy: Marcio Abreu, MD, BTT Medical Institute

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 maja 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2026

Ukończenie studiów (Szacowany)

1 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

17 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

4 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 kwietnia 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • BTT 25-001 SS

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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Badania kliniczne na Hyperthermia

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