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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. april 2026 opdateret af: 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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Aventura, Florida, Forenede Stater, 33160
        • BTT Medical Institute LLC

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single Arm with one hyperthermia treatment
one hyperthermia treatment
Andet: Hyperthermia
controlled induced hyperthermia

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Respiratory Parameters (Respiratory Rate)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Marc Abreu

Efterforskere

  • Ledende efterforsker: Marcio Abreu, MD, BTT Medical Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

17. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BTT 25-001 SS

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