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
NCT ID: NCT01462201
Last Updated: 2013-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
156 participants
INTERVENTIONAL
2012-07-31
2013-10-31
Brief Summary
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The secondary objective of this study is to assess subject satisfaction measured with a self-assessment questionnaire
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1 - Non Invasive Ultrasound
Group 1 3 visits - Measurement of abdominal circumferences 3 visits - Treatment with Ultrashape Contour I VER 3.1 4 visits - Follow up visits The intervention is non invasive ultrasound.
Non Invasive Ultrasound
Each treatment session is estimated to take approximately 60 minutes and will be performed on a bi-weekly basis.
Group 2 - Non Invasive Ultrasound
Group 2 3 visits - Treatment with Contour I VER 3.1 system 3 visits - Measurements of abdominal circumference 4 visits - Follow Up visits The intervention is non invasive ultrasound.
Non Invasive Ultrasound
Each treatment session is estimated to take approximately 60 minutes and will be performed on a bi-weekly basis.
Interventions
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Non Invasive Ultrasound
Each treatment session is estimated to take approximately 60 minutes and will be performed on a bi-weekly basis.
Eligibility Criteria
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Inclusion Criteria
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
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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Syneron Medical
INDUSTRY
UltraShape
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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US-0711
Identifier Type: -
Identifier Source: org_study_id