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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT02956720
Eligibility Criteria:
Inclusion Criteria:
1. Subject ≥18 and ≤60 years of age at the time of enrollment
2. Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper)
3. For women of child-bearing potential: negative urine pregnancy test
4. General good health confirmed by medical history and skin examination of the treated area
5. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
Exclusion Criteria:
1. History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator
2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
3. Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone
4. Previous liposuction in the treatment areas within 12 months
5. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
6. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
7. Childbirth within the last 12 months or women who are breastfeeding a child
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02956720
Study Brief:
Protocol Section:
NCT02956720