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