NCT02956720UnknownNot Applicable
Clinical Evaluation of UltraShape Power System in Conjunction With the U-Sculpt-N Transducer for Non-invasive Circumference Reduction
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Syneron Candela
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Outer thigh circumference reduction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject ≥18 and ≤60 years of age at the time of enrollment
- •Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper)
- •For women of child-bearing potential: negative urine pregnancy test
- •General good health confirmed by medical history and skin examination of the treated area
- •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
- •History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator
- •Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
- •Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone
- •Previous liposuction in the treatment areas within 12 months
- •History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
- •Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
- •Childbirth within the last 12 months or women who are breastfeeding a child
Arms & Interventions
single arm
Experimental
Intervention: UltraShape Power (Device)
Outcomes
Primary Outcomes
Outer thigh circumference reduction
Time Frame: 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
Time Frame: 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 Outcomes
- Subject satisfaction questionnaire(up to 24 week)
Investigators
Ronen Glesinger
Principal investigator
Syneron Candela
Study Sites (1)
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