A Multicenter,Two-Arm,Randomized,Controlled Study to Evaluate the Effectiveness of the UltraShape® Contour I VER 3.1 System for Non-Invasive Reduction in Abdominal Circumference
This study is currently recruiting participants.
Verified September 2012 by UltraShape
Sponsor:
UltraShape
Collaborator:
Syneron Medical
Information provided by (Responsible Party):
UltraShape
ClinicalTrials.gov Identifier:
NCT01462201
First received: October 17, 2011
Last updated: September 19, 2012
Last verified: September 2012
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Purpose
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 | Intervention |
|---|---|
|
Body Sculpting |
Device: Non Invasive Ultrasound |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Further study details as provided by UltraShape:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Reduction in circumference measurement of the abdomen from baseline
Secondary Outcome Measures:
- Assess subject satisfaction measured with a self-assessment questionnaire [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462201
Contacts
| Contact: Ruthie Amir, MD | +972-54-3003164 | Ruthie.Amir@syneron.com |
Locations
| United States, Louisiana | |
| Dr. William Patrick Coleman, III | Recruiting |
| Metairie, Louisiana, United States, 70006 | |
| Contact: William Patrick Coleman, MD 504-455-3180 | |
| Principal Investigator: William Patrick Coleman, MD | |
| United States, Maryland | |
| MD Laser Skin & Vein Institute | Recruiting |
| Hunt Valley, Maryland, United States, 21030 | |
| Contact: Robert Weiss, MD 410-666-2839 | |
| Principal Investigator: Robert Weiss, MD | |
| United States, New Jersey | |
| New-Jersey Plastic Surgery | Recruiting |
| Montclair, New Jersey, United States, 07042 | |
| Contact: Barry DiBernardo, MD 973-509-2000 | |
| Principal Investigator: Barry DiBernardo, MD | |
| United States, Texas | |
| Dr. Jeffrey Kenkel | Recruiting |
| Dallas, Texas, United States, 75390-9132 | |
| Contact: Jeffrey Kenkel, MD 214-645-3105 | |
| Principal Investigator: Jeffrey Kenkel, MD | |
| Israel | |
| Department of Plastic Surgery and Burns Rabin Medical Center - Beilinson Hospital | Recruiting |
| Petah Tikva, Israel, 49100 | |
| Contact: Dean Ad-El, MD 972-3-9376363 | |
| Principal Investigator: Dean Ad-El, MD | |
Sponsors and Collaborators
UltraShape
Syneron Medical
More Information
No publications provided
| Responsible Party: | UltraShape |
| ClinicalTrials.gov Identifier: | NCT01462201 History of Changes |
| Other Study ID Numbers: | US-0711 |
| Study First Received: | October 17, 2011 |
| Last Updated: | September 19, 2012 |
| Health Authority: | United States: Food and Drug Administration Israel: Ministry of Health |
Keywords provided by UltraShape:
|
focused ultrasound mechanical fat destruction Body Sculpting |
ClinicalTrials.gov processed this record on May 22, 2013