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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT02877004
Eligibility Criteria:
Inclusion Criteria:
1. over 18 years of age;
2. body weight of greater than 50 kg (110 pounds);
3. BMI between 25-29.9 kg/m2;
4. able to participate fully in all aspects of the study
5. understood and signed study informed consent
Exclusion Criteria:
1. used weight loss medications or participated in a weight loss program within past 30 days
2. currently taking supplements known to affect weight (garcinia cambogia, etc.)
3. weight fluctuations of 20 pounds or more in the past 6 months
4. implanted device (including pacemaker or lap band) in the targeted area of LLLT
5. known active eating disorder
6. known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression)
7. used an investigational drug within 30 days of study enrollment
8. currently pregnant or lactating, or are of child-bearing potential or are likely to become pregnant during the medication phase and unwilling to use a reliable form of contraception
9. history of any major cardiovascular events
10. current uncontrolled hypertension
11. clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease
12. Prior surgical intervention for body sculpting/weight loss
13. medical, physical, or other contraindications for body sculpting/weight loss
14. any medical condition known to affect weight levels or to cause bloating or swelling
15. diagnosis of, and/or taking medication for, irritable bowel syndrome
16. active infection, wound or other external trauma to the areas to be treated with the laser
17. known photosensitivity disorder;
18. current active cancer or currently receiving treatment for or within 1 year of cancer remission
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02877004
Study Brief:
Protocol Section:
NCT02877004