Effectiveness Study of the UltraShape® Contour I-Y for Non-Invasive Reduction in Abdominal Circum… (NCT01609699) | Clinical Trial Compass
UnknownNot Applicable
Effectiveness Study of the UltraShape® Contour I-Y for Non-Invasive Reduction in Abdominal Circumference
Israel30 participantsStarted 2012-08
Plain-language summary
The UltraShape® Contour I- Y system uses focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. It is intended for reduction in body circumference.
The primary objective of this study is to evaluate the efficacy of the Contour I - Y System on abdominal circumference reduction relative to baseline pretreatment values using different treatment methods.
The primary efficacy endpoint in this trial is Statistical Difference of Circumference reduction between Baseline measurement and at follow-up measurement.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Female or male subjects, 18-65 years of age at the time of enrollment
âś“. Abdominal and flank fat thickness of at least 1.5 cm prior to initial treatment (measurement by caliper)
âś“. For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment (measured in urine)
âś“. General good health confirmed by medical history and skin examination of the treated area
âś“. Written informed consent to participate in the study
âś“. Ability to comply with the requirements of the study
✓. BMI ≤ 30
Exclusion criteria
âś•. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
âś•. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
What they're measuring
1
The primary objective of this study is to evaluate the efficacy of the Contour I - Y System on abdominal circumference reduction relative to baseline pretreatment values using different treatment methods.
âś•. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
âś•. 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
âś•. Poor skin quality (i.e., laxity)
âś•. Abdominal wall diastasis or hernia on physical examination
âś•. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months