Cellulite Clinical Trial
Official title:
Safety and Efficacy of SofWave Treatment for Improvement of Cellulite Appearance Using
Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.
Eligible patients will receive 2 treatments (4 ± 2 weeks apart) on either one side (right or left) or both sides of the lateral/posterior upper thigh and/or buttocks using SofWave System with the Form applicator ('2X'). Treatment may be administered after the enrollment and screening at the first visit, or it may occur later following the enrollment and screening activities based on site scheduling availabilities. All patients will return to the clinic for one follow up visit at 3 months ± 1 week post last treatment (FU1). Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic. ;
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