UltraShape Device Using the U-Sculpt/VDF Transducer for Flanks Fat (NCT02465762) | Clinical Trial Compass
SuspendedNot Applicable
UltraShape Device Using the U-Sculpt/VDF Transducer for Flanks Fat
Stopped: Study design was amended to include a control - reregistered as NCT02465775
60 participantsStarted 2015-08
Plain-language summary
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive fat and circumference reduction.
Study subjects will undergo UltraShape treatments on the flanks area using the U-Sculpt/VDF Transducer - 60 subjects.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Signed informed consent to participate in the study.
✓. Female and male subjects, between 18 to 60 years of age at the time of enrolment
✓. Fitzpatrick Skin Type I to VI.
✓. Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).
✓. BMI interval: 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/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
What they're measuring
1
Efficacy flanks fat reduction
Timeframe: 4, 8 and 16 weeks post last treatment (Tx.3)