Performance of the ePrime System for Cellulite

Study Overview
=================
Brief Summary
-----------------
Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite.

Detailed Description
-----------------
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.

Official Title
-----------------
Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite

Conditions
-----------------
Cellulite

Intervention / Treatment
-----------------
* Device: ePrime


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects seeking treatment of cellulite in the upper thighs and buttocks areas. Subject have cellulite stage II or III as graded using Nurnberger-Muller scale clasification (Appendix III) Healthy female subjects ages 25 to 60 years of age Informed consent process completed and subject signed consent Willing to receive the proposed ePrime treatment and follow-up protocol Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence) Willing to have photographs taken of the treated areas to be used de-identified in evaluations, publications and presentations Exclusion Criteria: Subject had surgery or any other procedure for cellulite in the last 6 months Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding Known allergy to lidocaine or epinephrine or antibiotics Active malignancy or history of malignancy in the past 5 years Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process) Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion) History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen History of significant lymphatic drainage problems History of cancer which required lymph node biopsy or dissection Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course History of keloid scarring, abnormal wound healing and / or prone to bruising History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders Use of isotretinoin (Accutane®) within 6 months of treatment or during the study Subject on systemic corticosteroid therapy 6 months prior to and throughout the course of the study Dysplastic nevi in the area to be treated Participation in a study of another device or drug within 3 month prior to enrollment or during this study, if treatments of cellulite were involved Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will be used Subjects with history of severe edema As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: all subjects<br>Treatment with the ePrime radiofrequency microneedling device in the upper thighs and buttocks | Device: ePrime<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 3 months post treatment visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 1, 3, and 6 months post-treatment visit | 
| Subject satisfaction - by questionnaire | Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale | 1, 3, and 6 months post-treatment visit |