Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT02174003
Eligibility Criteria:
Inclusion Criteria:
* Male or female outpatients aged 18+.
* Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
* Able to communicate in English or Spanish with study personnel.
Exclusion Criteria:
* If patient has a medical condition or disorder that:
* Is unstable and clinically significant, or:
* Could, in the investigator's opinion, interfere with the accurate assessment of safety or efficacy of the procedure, including:
* Individuals who are using prescription drugs that may impair thermoregulatory cooling,
* Individuals with cardiovascular conditions or problems (uncontrolled hypertension, congestive heart failure, or documented evidence of coronary artery disease)
* Individuals with chronic conditions/diseases associated with a reduced ability initiate thermoregulatory cooling, including Parkinson's, multiple sclerosis, central nervous system tumors, and diabetes with neuropathy,
* Individuals with a fever the day of study intervention (if so, they will be rescheduled),
* Individuals with hypersensitivity to heat,
* Individuals with enclosed infections, be they dental, in joints, or in any other tissues,
* Women who are pregnant Obesity and overall size of subject.
* It will be up to the PI's discretion will consider BMI, waist circumference, and body fat composition when determining eligibility and safety of the individual.
* History of peripheral circulatory disease, for example peripheral vascular disease, deep vein thrombosis (DVT), or lymphedema.
* History of stroke, epilepsy or cerebral aneurisms
* Diabetes mellitus types I or II.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02174003
Study Brief:
Protocol Section:
NCT02174003