Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite.
Up to 60 healthy adult volunteers seeking cellulite treatment, females of 25 to 60 years of age, from multiple investigational sites. This is an open-label, multi-center study. Subjects in this study will receive a single subcutaneous treatment with the ePrime device in one treatment session according to the study protocol. Prior to treatments, tissue to be treated will be injected with tumescence or local dermal infiltration solution according to the protocol. Subjects will return for follow-up (FU) visits at: 1 week, 1 month, 3 months and 6 months following the treatment. Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
The main intent of the ePrime for cellulite is to utilize a minimally-invasive approach to directly deliver RF energy into tissue through pairs of micro-electrode needles and use temperature sensors within the needles to reliably create fractional thermal injuries within the skin.
Bowes Leyda
Miami, Florida, United States
David Goldberg
Hackensack, New Jersey, United States
Macrene Alexiades
New York, New York, United States
Girish Munavalli
Charlotte, North Carolina, United States
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs
Evaluate the efficacy of a single dermal and subcutaneous treatment with ePrime for the upper thighs and buttocks cellulite as assessed by blinded evaluators at 3 months post treatment visit.
Time frame: Baseline and 3 months post treatment visit
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs
Evaluate the efficacy of a single dermal and subcutaneous treatment with ePrime for the upper thighs and buttocks cellulite as assessed by blinded evaluators at 6 months post treatment visit.
Time frame: Baseline and 6 months post treatment visit
Number of Participants with Adverse Events
evaluate the safety of a single dermal and subcutaneous treatment with ePrime for the upper thighs and buttocks cellulite at 1 week post treatment, 1 month, 3 and 6 months following the treatment.
Time frame: day 0 up to 7 months
Improvement in cellulite compared to baseline
Improvement in cellulite compared to baseline, as assessed by study investigators, using Nurnberger-Muller scale at 1 month, 3 and 6 months post treatment visit.
Time frame: Baseline, 1 month, 3 and 6 months post treatment visit.
Investigator satisfaction - by questionnaire
Evaluate Investigator satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale
Time frame: 1, 3, and 6 months post-treatment visit
Subject satisfaction - by questionnaire
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Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale
Time frame: 1, 3, and 6 months post-treatment visit