Hyperthermia Safety Study Uses Temperature Management System to Gently Raise Participant's Body Temperature to a Fever-range Level in a Controlled Setting.

Part of paid clinical trials in Aventura, Florida.

Sponsor
Marc Abreu
Study ID
NCT07564440
Status
Enrolling By Invitation

Conditions

  • Safety Study

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Hyperthermia — OTHER
    controlled induced hyperthermia

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm with one hyperthermia treatment
    one hyperthermia treatment

Primary Outcome Measure

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline (pre-treatment) through post-treatment (48-hours post treatment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
BTT Medical Institute LLCAventuraFlorida33160-

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BTT Medical Institute LLC· Aventura, FL

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