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

Body Sculpting Clinical Trial

Official title:

A Multicenter,Two-Arm,Randomized,Controlled Study for the Evaluation of the Treatment of Adipose Tissue Using a Focused Ultrasound Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462201
• Other study ID #: US-0711
• Status: Completed
• Phase: N/A
• First received: October 17, 2011
• Last updated: November 10, 2013
• Start date: July 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: UltraShape
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Sculpting

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
UltraShape	Syneron Medical

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction in circumference measurement of the abdomen from baseline	5-6 months	No
Secondary	Assess subject satisfaction measured with a self-assessment questionnaire		5-6 months	No