Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction

NCT ID: NCT02154113

Last Updated: 2014-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-09-30

Brief 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.

Detailed 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.

Conditions

Abdominal Fat

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Velashape II device

Controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.

Group Type: ACTIVE_COMPARATOR

Velashape II

Intervention Type: DEVICE

All subjects receive 3 successive Velashape treatments every two weeks in the anterior abdomen.

Ultrashape

The UltraShape Contour I V3 uses focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption.

Group Type: ACTIVE_COMPARATOR

Ultrashape

Intervention Type: DEVICE

All subjects receive 3 successive Ultrashape treatments every two weeks in the anterior abdomen.

Interventions

Ultrashape

All subjects receive 3 successive Ultrashape treatments every two weeks in the anterior abdomen.

Intervention Type: DEVICE

Velashape II

All subjects receive 3 successive Velashape treatments every two weeks in the anterior abdomen.

Intervention Type: DEVICE

Other Intervention Names

Vela, Velashape

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneron Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shlomit Mann

Role: STUDY_DIRECTOR

Syneron Medical Ltd.

Locations

BC Laser & SkinCare Clinic

Surrey, British Columbia, Canada

Cosmedica

Pointe-Claire, Quebec, Canada

Countries

Canada

Other Identifiers

US-CA 02

Identifier Type: -

Identifier Source: org_study_id