CompletedNot Applicable

UltraShape Power for Abdominal Fat and Circumference Reduction

United States62 participantsStarted 2016-06-08

Plain-language summary

Prospective, one arm, baseline-controlled, clinical study for the evaluation of the UltraShape Power treatment using the U-Sculpt Power Transducer for non-invasive abdominal fat and circumference reduction.

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 in the treated area (measured by calibrated caliper).
✓. Body mass index (BMI): BMI between 22 to 30 (normal to overweight, but not obese).
✓. If female, not pregnant or lactating, 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 follow-up visit for women with child-bearing potential (e.g. not menopause).
✓. 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 or 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

Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound

Timeframe: Baseline and 16 weeks (4 weeks treatment + 12 week follow up)

Trial details

NCT IDNCT02748928

SponsorSyneron Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-02-15

Results submitted2019-02-12

View on ClinicalTrials.gov More Excess Abdominal Fat trials