Hyperthermia Safety Study Uses Temperature Management System to Gently Raise Participant's Body Temperature to a Fever-range Level in a Controlled Setting. (BTT)
2026年4月29日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Florida
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Aventura、Florida、アメリカ、33160
- BTT Medical Institute LLC
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
- 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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Single Arm with one hyperthermia treatment
one hyperthermia treatment
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controlled induced hyperthermia
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Baseline (pre-treatment) through post-treatment (48-hours post treatment)
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Incidence, type, and severity of treatment-emergent adverse events following whole-body hyperthermia (WBH).
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Baseline (pre-treatment) through post-treatment (48-hours post treatment)
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Change in Cardiovascular Vital Signs (Heart Rate)
時間枠：Baseline (pre-treatment) through post-treatment (48-hours post treatment)
|
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Baseline (pre-treatment) through post-treatment (48-hours post treatment)
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Change in Cardiovascular Vital Signs (Blood Pressure)
時間枠：Baseline (pre-treatment) through post-treatment (48-hours post treatment)]
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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)]
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Change in Comprehensive Metabolic Panel Renal Function Markers (Creatinine)
時間枠：Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
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Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
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Change in Comprehensive Metabolic Panel Renal Function (BUN)
時間枠：Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
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Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
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Change in Comprehensive Metabolic Panel Renal Function (eGFR)
時間枠：Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
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Change from baseline in renal function markers. (eGFR)
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Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
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Change in Comprehensive Metabolic Panel Hepatic Function (AST)
時間枠：Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
Change from baseline in Hepatic function markers. (AST)
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
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Change in Comprehensive Metabolic Panel Hepatic Function (ALT)
時間枠：Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
Change from baseline in Hepatic function markers. (ALT)
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Change in Comprehensive Metabolic Panel Hepatic Function (ALP)
時間枠：Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
Change from baseline in Hepatic function markers. (ALP)
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Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
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Change in Comprehensive Metabolic Panel Hepatic Function (Total Bilirubin)
時間枠：Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
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Change from baseline in Hepatic function markers. (Total Bilirubin)
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Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
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Change in Comprehensive Metabolic Panel Hepatic Function (GGT)
時間枠：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)
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Change in Hematologic Parameters (CBC- White Blood Cell Count)
時間枠：Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
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Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
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Change in Hematologic Parameters (CBC- Hemoglobin)
時間枠：Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
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Change in Hematologic Parameters (CBC- Hemoglobin) Change from baseline in hematologic indices.
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
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Change in Hematologic Parameters (CBC- Hematocrit)
時間枠：Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
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Change from baseline in hematologic indices.
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
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Change in Hematologic Parameters (CBC- Platelet Count)
時間枠：Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
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Change from baseline in hematologic indices.
|
Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
|
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Change in Hematologic Parameters (CBC- Erythrocyte Sedimentation Rate)
時間枠：Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
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Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
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Change in Hematologic Parameters (C-Reactive Protein)
時間枠：Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
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Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Respiratory Parameters (Respiratory Rate)
時間枠：Pretreatment through 48hrs. after the treatment
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Pretreatment through 48hrs. after the treatment
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Change in Respiratory Parameters (Oxygen Saturation)
時間枠：Pretreatment through 48hrs. after the treatment
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Change from baseline in oxygen Saturation.
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Pretreatment through 48hrs. after the treatment
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Change in Pulmonary Function (FEV1)
時間枠：Pretreatment and 48hrs. after the treatment
|
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Pretreatment and 48hrs. after the treatment
|
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Change in Pulmonary Function (FVC)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Marcio Abreu, MD、BTT Medical Institute
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月1日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2026年12月1日
試験登録日
最初に提出
2026年4月17日
QC基準を満たした最初の提出物
2026年4月29日
最初の投稿 (実際)
2026年5月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月4日
QC基準を満たした最後の更新が送信されました
2026年4月29日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。