NCT01462201CompletedNot Applicable
A Multicenter,Two-Arm,Randomized,Controlled Study for the Evaluation of the Treatment of Adipose Tissue Using a Focused Ultrasound Device
UltraShape10 sites in 2 countries156 target enrollmentStarted: July 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 156
- Locations
- 10
- Primary Endpoint
- 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
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Intra-procedural Inclusion criteria (prior to starting the treatment phase):
- •subjects are eligible to continue the study and participate in the treatment phase if she meets all of the following intra-procedural inclusion criteria:
- •For women of child-bearing potential: negative pregnancy test
- •Abdominal fat thickness of at least 1.5 cm prior to initial treatment (measurement by caliper)
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
- •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
- •Obesity (BMI > 30)
- •Childbirth within the last 12 months or breastfeeding women.
- •Any acute or chronic condition which, in the opinion of the Investigator, could interfere with the conduct of the study
- •Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months)
- •Inability to comply with circumference measurement procedure (e.g., inability to held breath for the required duration)
- •Participation in another clinical study within the last six months.
- •Previous body contouring treatments in the areas of the abdomen and flanks.
Outcomes
Primary Outcomes
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
Time Frame: 5-6 months
Reduction in circumference measurement of the abdomen from baseline
Secondary Outcomes
- Assess subject satisfaction measured with a self-assessment questionnaire(5-6 months)
Investigators
Study Sites (10)
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