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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Body Sculpting	Device: Non Invasive Ultrasound	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	156 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Multicenter,Two-Arm,Randomized,Controlled Study for the Evaluation of the Treatment of Adipose Tissue Using a Focused Ultrasound Device
Study Start Date :	July 2012
Actual Primary Completion Date :	October 2013
Actual Study Completion Date :	October 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 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.	Device: Non Invasive Ultrasound; Each treatment session is estimated to take approximately 60 minutes and will be performed on a bi-weekly basis.
Experimental: 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.	Device: Non Invasive Ultrasound; Each treatment session is estimated to take approximately 60 minutes and will be performed on a bi-weekly basis.

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. Assess subject satisfaction measured with a self-assessment questionnaire [ Time Frame: 5-6 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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Locations

United States, Louisiana
Dr. William Patrick Coleman, III
Metairie, Louisiana, United States, 70006
United States, Maryland
MD Laser Skin & Vein Institute
Hunt Valley, Maryland, United States, 21030
United States, New Jersey
New-Jersey Plastic Surgery
Montclair, New Jersey, United States, 07042
United States, Texas
Dr. Jeffrey Kenkel
Dallas, Texas, United States, 75390-9132
Israel
Department of Plastic Surgery and Burns Rabin Medical Center - Beilinson Hospital
Petah Tikva, Israel, 49100

Sponsors and Collaborators

UltraShape

Syneron Medical

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	UltraShape
ClinicalTrials.gov Identifier:	NCT01462201 History of Changes
Other Study ID Numbers:	US-0711
First Posted:	October 31, 2011
Last Update Posted:	November 13, 2013
Last Verified:	November 2013

Keywords provided by UltraShape:

focused ultrasound; mechanical fat destruction; Body Sculpting