Status:
COMPLETED
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
Lead Sponsor:
UltraShape
Collaborating Sponsors:
Syneron Medical
Conditions:
Body Sculpting
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT01462201
Start Date
July 1 2012
End Date
October 1 2013
Last Update
November 13 2013
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Dr. William Patrick Coleman, III
Metairie, Louisiana, United States, 70006
2
MD Laser Skin & Vein Institute
Hunt Valley, Maryland, United States, 21030
3
New-Jersey Plastic Surgery
Montclair, New Jersey, United States, 07042
4
Dr. Jeffrey Kenkel
Dallas, Texas, United States, 75390-9132