A Multi-Center Pilot Study to Assess the Safety and Efficacy of the VShape Ultra UltraSpeed Handpiece for Abdomen Circumference Reduction
Who can participate
Age range18 Years – 45 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 and 45 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).
* BMI interval: BMI between 20 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 childbearing potential (e.g., not menopausal).
* 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.
* Willingness to refrain from a change in diet / exercise / medication regimen for the entire course of the study.
* Willing to have photographs and images taken of the treated areas to be used, de-identified in evaluations, publications and presentations.
Exclusion Criteria:
* History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker / defibrillator, abnormal aortic aneurism.
* Known hyperlipidemia, diabetes mellitus, hepatitis, liver di…
What they're measuring
1
Average Circumference Reduction as Measured by Skin Fold and Photography