Hyperthermia for Safety Assessment
(BTT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of a device that gently raises body temperature to a fever-like level, a process known as hyperthermia. Participants will undergo one session with the device, followed by safety checks over three days. The process is straightforward, with all participants receiving the same treatment. The device has been used safely in other situations. The trial seeks adults who have not used treatments like painkillers in the past week and are generally healthy without major diseases such as heart or lung issues. As an unphased trial, this study offers participants the chance to contribute to innovative research in a safe and controlled environment.
Do I have to stop taking my current medications for the trial?
Yes, you must stop taking any medications, including pain relievers and anti-inflammatory drugs, at least 7 days before joining the study.
What prior data suggests that the Abreu BTT 700 Temperature Management System is safe?
Earlier research found that raising body temperature, known as hyperthermia, was safe, with no serious side effects reported. Most treatments successfully reached the desired temperature. Another study confirmed hyperthermia's safety and tolerability after reviewing all safety information. These studies suggest that hyperthermia usually does not cause serious side effects. However, individual experiences may vary, so discussing any concerns with the study doctors is important.12345
Why are researchers excited about this trial?
Hyperthermia is unique because it uses heat to target and treat medical conditions, which is different from traditional treatments like medication or surgery. Researchers are excited about this treatment because it has the potential to enhance the effectiveness of other therapies by increasing blood flow to the targeted area and making cancer cells more susceptible to radiation or chemotherapy. Unlike conventional methods, hyperthermia is non-invasive and focuses on precision by heating tissues to specific temperatures, potentially reducing side effects and improving outcomes.
What evidence suggests that the Abreu BTT 700 Temperature Management System is effective for safety assessment?
Research has shown that raising body temperature, known as hyperthermia, can aid medical treatments. Studies have found that hyperthermia enhances cancer treatments by improving tumor response and increasing survival rates. The treatment is generally safe, with most patients reaching the desired temperature without serious side effects. In some cases, hyperthermia alone has produced promising results as a treatment. While these findings primarily relate to cancer, they suggest potential benefits in other areas as well. Participants in this trial will receive a single hyperthermia treatment to assess its safety.12467
Who Is on the Research Team?
Marcio Abreu, MD
Principal Investigator
BTT Medical Institute
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 65 with normal blood pressure and heart rate, who haven't taken any medications (including painkillers or anti-inflammatories) in the past week. Participants must be able to understand the study and agree to follow all procedures.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo one hyperthermia treatment session using the BTT 700 Temperature Management System
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Hyperthermia
Trial Overview
The study tests a device called the Abreu BTT 700 Temperature Management System, which gently raises body temperature to mimic a mild fever. All participants receive one session with safety checks before and after treatment over three days.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
one hyperthermia treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marc Abreu
Lead Sponsor
Citations
Predictors of Successful Whole-Body Hyperthermia in Cancer ...
WBH proved to be safe, with no serious adverse events and target temperature reached in 90% of treatments. Two factors—higher serum creatinine ...
2.
aacrjournals.org
aacrjournals.org/cancerrescommun/article/6/2/273/774185/The-MATTERS-Trial-Safety-and-Tolerability-of-WholeSafety and Tolerability of Whole-Body Hyperthermia at 41.50 ...
The MATTERS trial demonstrates that WBHT at 41.50°C, delivered with the TempoCure device, is a safe and well-tolerated treatment for advanced ...
Enhancing Cancer Therapy with Hyperthermia - PMC - NIH
Although this strategy can increase treatment effectiveness, it may also lead to more severe side effects and poorer treatment outcomes [39].
Review The role of hyperthermia in the treatment of locally ...
44 This review included six randomized studies published from 1987 to 2009, and showed better outcomes with the addition of hyperthermia to radiotherapy.44 ...
Locoregional Hyperthermia in Cancer Treatment
Several studies reported worthy efficacy, feasibility, and safety of HT and mEHT concerning tumor response, survival, and relapse-free improvements in several ...
Registry Trial to Evaluate the Safety and Efficacy of ...
To carry out a registry trial to evaluate the safety and efficacy of hyperthermia delivered by a repurposed short wave diathermy unit working at 27.1 MHz along ...
Clinical Evidence for Thermometric Parameters to Guide ...
Hyperthermia (HT) is a cancer treatment modality which targets malignant tissues by heating to 40–43 °C. In addition to its direct antitumor effects, HT ...
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