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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT02711618
Eligibility Criteria:
Inclusion Criteria:
subject is eligible to participate in the study if he or she meets all the following inclusion criteria:
1. Signed informed consent to participate in the study.
2. Female and male subjects,18 and 60 years of age at the time of enrolment
3. Fitzpatrick Skin Type I to VI.
4. Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper).
5. BMI above 28 (normal to overweight).
6. If female, not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e. oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
7. Negative urine pregnancy test as tested before the first treatment for women with bearing potential (e.g. not menopause). In addition, negative pregnancy following pregnancy inquiry for each visit (treatments and follow up), starting from the second treatment.
8. General good health confirmed by medical history and skin examination of the treated area.
9. Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
10. Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study.
11. Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations
Exclusion Criteria:
A subject is not eligible for participation in this study if he/she meets any of the following exclusion criteria:
1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
2. Current hyperlipidemia, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
3. Previous liposuction or body contouring procedures in the treatment areas of the abdomen or flanks. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing.
4. Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area.
5. Poor skin quality (i.e., laxity).
6. Abdominal wall diastasis or hernia on physical examination.
7. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months.
8. Childbirth within the last 12 months or breastfeeding women.
9. Any acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study.
10. Unstable weight within the last 6 months (i.e., ± 3 percent weight change in the prior six months).
11. Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration).
12. Abdominal fat thickness lower than 2.5 cm after strapping.
13. Participation in another clinical study within the last 6 months.
14. Non-invasive body-contouring procedures in the treatment area completed less than twelve months prior to study enrollment.
15. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02711618
Study Brief:
Protocol Section:
NCT02711618