Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02154113
• Date of registration: 27/05/2014
• Prospective Registration: No
• Primary sponsor: Syneron Medical
• Public title: Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction
• Scientific title: Baseline Controlled Two-arm Multi-Center Study to Evaluate the Safety and Efficacy of Combined Multi-Focus Treatments of UltraShape® Contour I V3 System and VelaShape II Device for Non-Invasive Circumference Reduction
• Date of first enrolment: October 2012
• Target sample size: 21
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02154113
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Shlomit Mann
• Affiliation: Syneron Medical Ltd.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Fat thickness of at least 1.5 cm in the anterior abdominal and flanks prior to
initial treatment (measurement by caliper)

2. For women of child-bearing potential: negative pregnancy test in the 24 hour period
prior to enrollment and 24 hour period prior to each treatment or FU visit (measured
in urine)

3. General good health confirmed by medical history and skin examination of the treated
area

4. Written informed consent to participate in the study

5. Ability to comply with the requirements of the study

6. BMI= 30

Exclusion Criteria:

1. History of hypertension, ischemic heart disease, valvular heart disease, congestive
heart failure, pacemaker/defibrillator, abdominal aortic aneurism

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 areas

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 women who suckling a child

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

15. Previous body contouring treatments in the treatment areas



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Abdominal Fat

Intervention(s)

Device: Ultrashape

Device: Velashape II

Primary Outcome(s)

Difference in circumference reduction between baseline and follow-up visits [Time Frame: Base line, 2 and 12 weeks post last treatment]

Secondary Outcome(s)

Adverse Events [Time Frame: The duration of the study, an expected average of 5 months.]

Secondary ID(s)

US-CA 02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors