UltraShape Power in Combination With U-sculpt-n Transducer

Syneron Candela

Status: Unknown

Conditions: Circumference Reduction

Treatments: Device: UltraShape Power

Study type: Interventional

Funder types: Industry

Identifiers

NCT02956720

DHF21321

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

single arm

Experimental group

Treatment:

Device: UltraShape Power