Cellulite Clinical Trial
Official title:
Clinical Study to Evaluate the Safety and Efficacy Performance of the Profound System Using the Dermal and Sub-dermal (SubQ) Cartridges for the Treatment of Cellulite
Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite.
Up to 60 healthy female volunteers, seeking cellulite treatment, 18 to 60 years of age from
up to 3 investigational sites.
Prospective, open-label, baseline-controlled, two arms, randomized, clinical study to
evaluate the Profound device using the Dermal and SubQ Cartridges for minimally-invasive
treatment of the upper thighs and buttocks cellulite appearance.
The treatment areas of the study subjects will be divided into two arms:
1. Arm 1 - the upper thigh/buttock on the left or right side of the body will undergo a
single Profound treatment utilizing the Dermal and SubQ Cartridges
2. Arm 2 - the contralateral upper thigh/buttock side of the body will undergo a single
Profound treatment utilizing the SubQ Cartridge only.
Methodology described in protocol to evaluate efficacy of treatments will be carried out at
each visit.
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