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
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01462201 |
Recruitment Status :
Completed
First Posted : October 31, 2011
Last Update Posted : November 13, 2013
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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 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 |
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.
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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. |
- 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
- Assess subject satisfaction measured with a self-assessment questionnaire [ Time Frame: 5-6 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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)
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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
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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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462201
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 |
Responsible Party: | UltraShape |
ClinicalTrials.gov Identifier: | NCT01462201 |
Other Study ID Numbers: |
US-0711 |
First Posted: | October 31, 2011 Key Record Dates |
Last Update Posted: | November 13, 2013 |
Last Verified: | November 2013 |
focused ultrasound mechanical fat destruction Body Sculpting |