UnknownNot Applicable

UltraShape Power in Combination With U-sculpt-n Transducer

Israel24 participantsStarted 2017-01

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Outer thigh circumference reduction

Timeframe: up to 24 week

Treatment-related adverse events

Timeframe: up to 24 week

Trial details

NCT IDNCT02956720

SponsorSyneron Candela

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05

Contact for this trial

Ketty Shkolnik, Ph.D.

+972-73-2442268 kettys@syneron-candela.com

View on ClinicalTrials.gov More Circumference Reduction trials