Circumference Reduction
Conditions
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.
Interventions
DEVICEUltraShape Power
non-invasive body contouring procedure
Sponsors
Syneron Candela
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, single arm
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outer thigh circumference reduction | up to 24 week | To evaluate circumference reduction of outer thigh post treatment with UltraShape Power device used with the U-Sculpt-N transducer versus control side. |
| Treatment-related adverse events | up to 24 week | The frequency and severity of all treatment-related adverse events during and after using the UltraShape Power device used with the U-Sculpt-N transducer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject satisfaction questionnaire | up to 24 week | The assessment of subject satisfaction with treatment will be recorded during relevant visits (starting following the first treatment) using a 5-point Likert scale |
Countries
Israel
Contacts
Primary ContactKetty Shkolnik, Ph.D.
Outcome results
None listed