Treatment for Improvement of Cellulite Appearance Using Form Applicator

Study Overview
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Brief Summary
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Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.

Detailed Description
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Eligible patients will receive 2 treatments (4 ± 2 weeks apart) on either one side (right or left) or both sides of the lateral/posterior upper thigh and/or buttocks using SofWave System with the Form applicator ('2X'). Treatment may be administered after the enrollment and screening at the first visit, or it may occur later following the enrollment and screening activities based on site scheduling availabilities. All patients will return to the clinic for one follow up visit at 3 months ± 1 week post last treatment (FU1). Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.

Official Title
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Safety and Efficacy of SofWave Treatment for Improvement of Cellulite Appearance Using

Conditions
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Cellulite

Intervention / Treatment
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* Device: Sofwave


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female subjects > 18 years of age and < 60 years of age 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. Have visible cellulite in the upper thigh and/or buttock areas. Seeking treatment of cellulite in the upper thigh and/or buttock areas. Stable weight nominally ±5% for at least past 6 months Subject agrees to maintain her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the study course. Subject did not undergo invasive or energy-based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months. Subject did not use topical based cellulite treatments for prior 6 months and will not use during the trial (except for the study related procedures) Subject agrees not to undergo any other cellulite treatments for a period of 3 months following SofWave treatment Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications, and presentations. Able and willing to comply with all visits, treatments and evaluations schedules and requirements. Able to understand and provide written Informed Consent. Exclusion Criteria: Pregnant or planning to become pregnant during the duration of the study, having given birth less than 3 months ago, and/or breast feeding Currently heavy smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years BMI>=30kg/m2 Non-stable weight nominally ±5% for at least past 6 months Currently taking or has taken diet pills or weight control supplements within the past month History of severe migraine tendency History of Epileptic seizures History of chronic drug or alcohol abuse History of coagulopathy(ies) and/or on anticoagulant medication History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising Medical disorder that would hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.) Active implanted device such as a pacemaker, defibrillator, cochlear implants, nerve/brain stimulators or drug delivery system Known allergy to lidocaine or epinephrine or antibiotics Active malignancy or history of malignancy in the past 5 years 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 investigator may interfere with the anesthesia, treatment, or healing process) 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 epidermal or dermal disorders (particularly involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders. Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area. Severe solar elastosis on the intended to treat area. Significant scarring, atrophic scars in the area to be treated, or has a history of atrophic scars or keloids or prone to bruising Tattoo or former tattoo at or near treatment area Presence of an implant (metal or plastic) in or adjacent to area of intended treatment (vascular stent, or implants in the hips, knees, etc) Inability to understand the protocol or to give informed consent On-going use of psychiatric medication Unable or unwilling to comply with the study requirements and procedures Unwilling to have research photos taken of treatment areas Currently enrolled in a clinical study of any other unapproved investigational drug or device Any other condition that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject

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: Cellulite<br> | Device: Sofwave<br>* The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues. Other Names: SUPERB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome Measure: | Rate of improvement in the appearance of cellulite on the upper thigh/buttock area following Sofwave treatments based on 6 points simplified Cellulite Severity Scale (CSS), as evaluated by independent masked reviewers. | 3 months post treatment follow-up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper thigh, buttock, skin laxity