Clinical and Biological Safety Study of the BTT Hyperthermia in Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- 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)
排除标准
- •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
研究组 & 干预措施
Single Arm with one hyperthermia treatment
one hyperthermia treatment
干预措施: Hyperthermia (Other)
结局指标
主要结局
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 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
Change in Cardiovascular Vital Signs (Heart Rate)
时间窗: 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
Change in Cardiovascular Vital Signs (Blood Pressure)
时间窗: 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
Change in Comprehensive Metabolic Panel Renal Function Markers (Creatinine)
时间窗: 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)
Change in Comprehensive Metabolic Panel Renal Function (BUN)
时间窗: 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)
Change in Comprehensive Metabolic Panel Renal Function (eGFR)
时间窗: 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)
Change in Comprehensive Metabolic Panel Hepatic Function (AST)
时间窗: 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)
Change in Comprehensive Metabolic Panel Hepatic Function (ALT)
时间窗: 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)
Change in Comprehensive Metabolic Panel Hepatic Function (ALP)
时间窗: 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)
Change in Comprehensive Metabolic Panel Hepatic Function (Total Bilirubin)
时间窗: 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)
Change in Comprehensive Metabolic Panel Hepatic Function (GGT)
时间窗: 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)
Change in Hematologic Parameters (CBC- White Blood Cell Count)
时间窗: 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
Change in Hematologic Parameters (CBC- Hemoglobin)
时间窗: 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
Change in Hematologic Parameters (CBC- Hematocrit)
时间窗: 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
Change in Hematologic Parameters (CBC- Platelet Count)
时间窗: 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
Change in Hematologic Parameters (CBC- Erythrocyte Sedimentation Rate)
时间窗: 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
Change in Hematologic Parameters (C-Reactive Protein)
时间窗: 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
次要结局
- Change in Respiratory Parameters (Respiratory Rate)(Pretreatment through 48hrs. after the treatment)
- Change in Respiratory Parameters (Oxygen Saturation)(Pretreatment through 48hrs. after the treatment)
- Change in Pulmonary Function (FEV1)(Pretreatment and 48hrs. after the treatment)
- Change in Pulmonary Function (FVC)(Pretreatment and 48hrs. after the treatment)
研究者
Marc Abreu
Chief Medical Officer
BTT Medical Institute LLC