Cellulite
Conditions
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.
Interventions
DEVICEePrime
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.
Sponsors
Syneron Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects seeking treatment of cellulite in the upper thighs and buttocks areas. 2. Subject have cellulite stage II or III as graded using Nurnberger-Muller scale clasification (Appendix III) 3. Healthy female subjects ages 25 to 60 years of age 4. Informed consent process completed and subject signed consent 5. Willing to receive the proposed ePrime treatment and follow-up protocol 6. 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) 7. Willing to have photographs taken of the treated areas to be used de-identified in evaluations, publications and presentations
Exclusion criteria
1. Subject had surgery or any other procedure for cellulite in the last 6 months 2. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding 3. Known allergy to lidocaine or epinephrine or antibiotics 4. Active malignancy or history of malignancy in the past 5 years 5. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator 6. 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) 7. 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) 8. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications 9. Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen 10. History of significant lymphatic drainage problems 11. History of cancer which required lymph node biopsy or dissection 12. 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 13. History of keloid scarring, abnormal wound healing and / or prone to bruising 14. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders 15. Use of isotretinoin (Accutane®) within 6 months of treatment or during the study 16. Subject on systemic corticosteroid therapy 6 months prior to and throughout the course of the study 17. Dysplastic nevi in the area to be treated 18. 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 19. Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will be used 20. Subjects with history of severe edema 21. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs | Baseline and 3 months post treatment visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject satisfaction - by questionnaire | 1, 3, and 6 months post-treatment visit | Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale |
| Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs | Baseline and 6 months post treatment visit | 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. |
| Number of Participants with Adverse Events | day 0 up to 7 months | 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. |
| Improvement in cellulite compared to baseline | Baseline, 1 month, 3 and 6 months post treatment visit. | 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. |
| Investigator satisfaction - by questionnaire | 1, 3, and 6 months post-treatment visit | Evaluate Investigator satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale |
Countries
United States
Outcome results
None listed