UnknownNot Applicable

Non-Invasive Abdominal Fat Reduction With BMI Above 28

United States47 participantsStarted 2015-10-29

Plain-language summary

Prospective, one arm, baseline-controlled clinical study for the evaluation of UltraShape contour I V3 for non-invasive fat reduction. The study will conduct using the UltraShape contour I V3 using U-Sculpt/VDF transducer on the abdomen.

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 enrolment
✓. Fitzpatrick Skin Type I to VI.
✓. Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper).
✓. BMI above 28 (normal to overweight).
✓. 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).
✓. Negative urine pregnancy test as tested before the first treatment for women with bearing potential (e.g. not menopause). In addition, negative pregnancy following pregnancy inquiry for each visit (treatments and follow up), starting from the second treatment.
✓. 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
✕. Current hyperlipidemia, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
✕. Previous liposuction or body contouring procedures in the treatment areas of the abdomen or flanks. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing.
✕. Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area.
✕. Poor skin quality (i.e., laxity).
✕. Abdominal wall diastasis or hernia on physical examination.
✕. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months.
✕. Childbirth within the last 12 months or breastfeeding women.

What they're measuring

Change in abdominal fat thickness compared to baseline

Timeframe: Baseline and 12 weeks

Trial details

NCT IDNCT02711618

SponsorSyneron Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10

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