Clinical trial NCT01462201: 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
Official title: A Multicenter,Two-Arm,Randomized,Controlled Study for the Evaluation of the Treatment of Adipose Tissue Using a Focused Ultrasound Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Sculpting
Keywords: focused ultrasound
mechanical fat destruction
Body Sculpting
Lead sponsor: UltraShape
Sponsor class: INDUSTRY
Collaborators: name: Syneron Medical
First posted: 2011-10-31
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Female or male subjects, 18 and 65 years of age at the time of enrollment
2. Abdominal fat thickness of at least 1.5 cm (measurement by caliper)
3. For women of child-bearing potential:

   1. negative urine pregnancy test.
   2. Women of child bearing age are required to be using an acceptable form of birth control for the duration of the study.
4. General good health confirmed by medical history and skin examination of the treated area
5. Written informed consent to participate in the study
6. Ability to comply with the requirements of the study
7. 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:
8. For women of child-bearing potential: negative pregnancy test
9. Abdominal fat thickness of at least 1.5 cm prior to initial treatment (measurement by caliper)

Exclusion Criteria:

1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurysm
2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy.
3. Previous liposuction in the treatment area
4. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
5. 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
6. Poor skin quality (i.e., laxity)
7. Abdominal wall diastasis or hernia on physical examination
8. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
9. Obesity (BMI \> 30)
10. Childbirth within the last 12 months or breastfeeding women.
11. Any acute or chronic condition which, in the opinion of the Investigator, could interfere with the conduct of the study
12. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months)
13. Inability to comply with circumference measurement procedure (e.g., inability to held breath for the required duration)
14. Participation in another clinical study within the last six months.
15. Previous body contouring treatments in the areas of the abdomen and flanks.

Primary outcomes:
measure: 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
timeFrame: 5-6 months
Secondary outcomes:
measure: Assess subject satisfaction measured with a self-assessment questionnaire
timeFrame: 5-6 months
Other outcomes:
Locations:
city: Metairie
country: United States
facility: Dr. William Patrick Coleman, III
state: Louisiana
city: Hunt Valley
country: United States
facility: MD Laser Skin & Vein Institute
state: Maryland
city: Montclair
country: United States
facility: New-Jersey Plastic Surgery
state: New Jersey
city: Dallas
country: United States
facility: Dr. Jeffrey Kenkel
state: Texas
city: Petah Tikva
country: Israel
facility: Department of Plastic Surgery and Burns Rabin Medical Center - Beilinson Hospital
Study officials:
References: