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

Completed · Not applicable

Conditions studied: Body Sculpting

In brief

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

Key facts

Study ID

NCT01462201

Run by

UltraShape

People needed

156

Starts

2012-07-01

Expected to finish

2013-10-01

Last updated by the study team

2013-11-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• BMI ≤ 30
• 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)

You may not qualify if…

• 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.

Where it is running

• Dr. William Patrick Coleman, III — Metairie, Louisiana, United States
• MD Laser Skin & Vein Institute — Hunt Valley, Maryland, United States
• New-Jersey Plastic Surgery — Montclair, New Jersey, United States
• Dr. Jeffrey Kenkel — Dallas, Texas, United States
• Department of Plastic Surgery and Burns Rabin Medical Center - Beilinson Hospital — Petah Tikva, Israel

Full record on ClinicalTrials.gov

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