UltraShape Power in Combination With U-sculpt-n Transducer

NCT ID: NCT02956720

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-10-31

Brief Summary

Prospective, open label, self - controlled, single arm, clinical study to assess the performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for circumference reduction versus self-control.

Conditions

Circumference Reduction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

Group Type: EXPERIMENTAL

UltraShape Power

Intervention Type: DEVICE

non-invasive body contouring procedure

Interventions

UltraShape Power

non-invasive body contouring procedure

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject ≥18 and ≤60 years of age at the time of enrollment

2. Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper)

3. For women of child-bearing potential: negative urine pregnancy test

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

5. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

Exclusion Criteria

1. History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator

2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease

3. Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone

4. Previous liposuction in the treatment areas within 12 months

5. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing

6. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months

7. Childbirth within the last 12 months or women who are breastfeeding a child

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneron Candela

INDUSTRY

Sponsor Role: lead

Responsible Party

Ronen Glesinger

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beit Noah

Ramat Gan, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ketty Shkolnik, Ph.D.

Role: CONTACT

kettys@syneron-candela.com

+972-73-2442268

Facility Contacts

Ronen Glesinger, Dr

Role: primary

Other Identifiers

DHF21321

Identifier Type: -

Identifier Source: org_study_id