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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT01708460
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age 30 to 65 years.
* Subject in good health.
* Skin laxity in the buttocks and thighs.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated and/or weight loss through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
* Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: a) Postmenopausal for at least 12 months prior to study; b) Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six months prior to study enrollment.
Exclusion Criteria:
* Presence of an active systemic or local skin disease that may affect wound healing.
* BMI equal to or greater than 40.
* Excessive subcutaneous fat in the buttocks and thighs.
* Excessive skin laxity in the buttocks and thighs.
* Significant weight fluctuation (±10 lbs) in the past 6 months.
* Taking weight-loss medications/supplements.
* Surgical or non-surgical treatments to the target areas in the last 12 months, e.g., liposuction.
* Inability to understand the protocol or to give informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT01708460
Study Brief:
Protocol Section:
NCT01708460