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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT00953160
Eligibility Criteria:
Inclusion Criteria:
* Female or Male
* Minimum age of 18 years
* Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study.
* Post-menopausal, or on birth control with no plans to become pregnant for the duration of the study (female only)
* Minimum Body Mass Index of 20
* Visible fat in the area to be treated Area to be treated to measure at least 20.0mm in vertical fold, as measured with industry standard fat caliper
* Subject must be able to read, understand and sign the Consent Form
* Subject must adhere to the follow-up schedule and study instructions
* Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study (within 6 lbs of initial weight)
Exclusion Criteria:
* Significant weight fluctuation (+/-10 lbs) in the past 6 months
* Taking weight-loss medications/supplements
* Participation in any other clinical study
* Cellulite treatment within 3 months of the treatment
* Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction
* Prior treatment to the target area within the last 12 months
* Arteriosclerosis or weakened blood vessels
* Heart disease
* Thromboembolic disease
* Diagnosed or documented immune system disorders
* Bleeding disorders.
* Presence of uncontrolled hypertension
* Taking prescription anticoagulants
* History of keloid formation
* Malignant tumors in the target area
* Diabetes
* Any disease or condition that could impair wound healing
* Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles
* Infection in the target area
* Implanted electrical device(s)
* Pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00953160
Study Brief:
Protocol Section:
NCT00953160