CompletedNot Applicable

SlimShape Device for Abdominal Fat and Circumference Reduction

United States70 participantsStarted 2017-01-13

Plain-language summary

Prospective, one-arm, baseline-controlled, clinical study for the evaluation of the SlimShape device for non-invasive abdominal fat and circumference reduction. Study subjects will undergo SlimShape treatments on the abdominal area.

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
✓. BMI interval: 18.5 ≤ BMI ≤ 30 (normal to overweight, but not obese).
✓. If female, not pregnant, lactating and 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 childbearing potential (e.g. not menopause).
✓. General good health confirmed by medical history and skin examination of the treated area.
✓. Willing to follow the treatment and follow-up schedule and post-treatment care instructions.

Exclusion criteria

✕. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
✕. Current 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 Fat Thickness at Final Follow-up Compared to Baseline

Timeframe: Baseline and 12 weeks follow-up

Trial details

NCT IDNCT02999763

SponsorSyneron Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05-03

Results submitted2019-03-14

View on ClinicalTrials.gov More Fat Disorder trials