Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction

Abdominal Fat Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154113
• Other study ID #: US-CA 02
• Status: Completed
• Phase: N/A
• First received: May 27, 2014
• Last updated: May 29, 2014
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: May 2014
• Source: Syneron Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the clinical performance of the Ultrashape system with VelaShape II device for reduction of the waist.

Description:

UltraShape® Contour I V3 system is a non-invasive (not breaking the skin) focused ultrasound for body contouring purposesdesigned to selectively disrupt sub-dermal fat cells employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves, remain intact. There are no thermal effects. Fat-cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.

VelaShape is a non-invasive device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Fat

Intervention

Device:
• Ultrashape
All subjects receive 3 successive Ultrashape treatments every two weeks in the anterior abdomen.
• Velashape II
All subjects receive 3 successive Velashape treatments every two weeks in the anterior abdomen.

Locations

Country	Name	City	State
Canada	Cosmedica	Pointe Claire	Quebec
Canada	BC Laser & SkinCare Clinic	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Syneron Medical

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject Satisfaction Scores	Subject Satisfaction Scores using the Global Aesthetic Improvement (GAI) Scale at each treatment and follow-up time point post treatment: 2 week, 4 week, 6 week, 8 week, 10 week and 12 week in a study.	2, 4, 6, 8,10 and 12 week in a study.	No
Primary	Difference in circumference reduction between baseline and follow-up visits	The primary efficacy endpoint in this trial is the statistical difference in circumference reduction between Control (baseline measurement, Vist 2 / Day 0) and two points of follow-up measurement: 2 weeks (Visit 5 / Day 42) and 12 weeks (Visit 8 / Day 112) following the last Tx session. The following procedure will be used to compute the Circumference Difference primary endpoint:	Base line, 2 and 12 weeks post last treatment	No
Secondary	Adverse Events	Safety will be evaluated based on the incidence and severity of adverse events caused by the treatments	The duration of the study, an expected average of 5 months.	Yes