A Multicenter,2-Arm,Randomized,Controlled Study Evaluate the Effectiveness of the UltraShape® Con… (NCT01462201) | Clinical Trial Compass
CompletedNot Applicable
A Multicenter,2-Arm,Randomized,Controlled Study Evaluate the Effectiveness of the UltraShape® Contour I VER 3.1 System for Non-Invasive Reduction in Abdominal Circumference
United States, Israel156 participantsStarted 2012-07
Plain-language summary
The primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1 System on abdominal midsection circumference reduction relative to no treatment.
The secondary objective of this study is to assess subject satisfaction measured with a self-assessment questionnaire
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Female or male subjects, 18 and 65 years of age at the time of enrollment
✓. Abdominal fat thickness of at least 1.5 cm (measurement by caliper)
✓. For women of child-bearing potential:
✓. negative urine pregnancy test.
✓. Women of child bearing age are required to be using an acceptable form of birth control for the duration of the study.
✓. General good health confirmed by medical history and skin examination of the treated area
✓. Written informed consent to participate in the study
✓. Ability to comply with the requirements of the study
Exclusion criteria
✕. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurysm
✕. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy.
✕. Previous liposuction in the treatment area
✕. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
✕
What they're measuring
1
The primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1 System on abdominal midsection circumference reduction relative to no treatment
. 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