CompletedNot Applicable

VelaShape III & UltraShape Power for Thigh Circumference Reduction

United States16 participantsStarted 2018-02-19

Plain-language summary

Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III combined with UltraShape Power treatment for non-invasive circumference reduction to the thighs.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Signed informed consent to participate in the study.
✓. Female and male subjects, 18 and 60 years of age at the time of enrollment.
✓. Fitzpatrick Skin Type I to VI.
✓. Fat thickness of at least 1.5 cm (measured by calibrated caliper).
✓. BMI interval: 22 ≤ BMI ≤ 30 (normal to overweight, but not obese).
✓. Female subjects 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).
✓. In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with child-bearing potential (e.g. not menopausal).
✓. General good health confirmed by medical history and skin examination of the treated area.

Exclusion criteria

✕. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism.
✕. Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease.
✕. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
✕. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
✕. Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone.
✕. Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction.
✕. Previous body contouring procedures in the treatment area within 12 months.
✕. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing.

What they're measuring

Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements

Timeframe: At 12 weeks after the third treatment (week 16) for each subject

Trial details

NCT IDNCT03430245

SponsorSyneron Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-30

Results submitted2019-12-10

View on ClinicalTrials.gov More Circumference Reduction trials