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Hyperthermia for Safety Assessment

(BTT Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Marc Abreu
Must not be taking: Analgesics, Anti-inflammatory drugs
Disqualifiers: Cardiovascular, Auto-immune, Pulmonary, Neurological, Cancer, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MA

Marcio Abreu, MD

Principal Investigator

BTT Medical Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

* 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.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants undergo one hyperthermia treatment session using the BTT 700 Temperature Management System

1 day
1 visit (in-person)

Safety Assessment

Safety assessments conducted before the session, about two hours afterward, on the next day, and again on the third day after the session

3 days
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 hours post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • Hyperthermia

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single Arm with one hyperthermia treatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Marc Abreu

Lead Sponsor

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