Profound Dermal and SubQ Cartridges for the Treatment of Cellulite

Study Overview
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Brief Summary
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Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite.

Detailed Description
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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: 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 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.

Official Title
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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

Conditions
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Cellulite

Intervention / Treatment
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* Device: Profound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent to participate in the study. Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment Fitzpatrick Skin Type I to VI. Subjects seeking treatment of cellulite in the upper thighs and buttocks areas. Subject cellulite stage II or III as graded using Nurnberger-Muller scale classification (Appendix III). Not pregnant, 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). Negative urine pregnancy test as tested prior to each treatment and at the last visit for women of child bearing potential (e.g. not menopause). General good health confirmed by medical history and skin examination of the treated area. Willing to receive the proposed Profound treatment. Willing to follow the treatment and follow-up schedule and post-treatment care instructions. Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations. Exclusion Criteria: Subject cellulite stage 0 or I as graded using Nurnberger-Muller scale classification (Appendix III). 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 anti-coagulative 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 treatment 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. 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 that might make it unsafe for subject to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Profound treatment to small areas<br>Single Profound treatment with the Dermal and/or SubQ cartridges to bra bulge, above the knees or upper arms | Device: Profound<br>* The main intent of the Profound Dermal and Subdermal cartridges for cellulite treatment is to utilize a minimally-invasive approach to directly deliver radiofrequency (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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations | Evaluate the improvement in global aesthetic appearance of cellulite in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1,3 and 6 months post treatment visit. Investigators used the following scale: 0=No Change; 1= 1-24% improvement; 2=25-49% improvement; 3=50-74% improvement; 4=75-100% improvement. The analysis calculates the improvement over 25% (grades 2-4) | 1,3 and 6 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations | Evaluate the improvement in skin tightening in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1 and 6 months post treatment visit. Investigators used the following scale: (0) No tightening/firmness; (1) Slightly visible tightening/firmness; (2) Visible tightening/firmness; (3) Very visible tightening/firmness. The analysis calculates the skin tightening improvement graded: (2) Visible tightening/firmness and (3) Very visible tightening/firmness | 1, 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 [(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied]. The analysis quantify investigator satisfaction (grades 1-2) | 1, 3, and 6 months post-treatment visit | 
| Subject Satisfaction and Improvement - by Questionnaire | Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction and improvement scale [(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied]. The analysis quantify subject satisfaction (grades 1-2) | 1, 3, and 6 months post-treatment visit |