Study of the Cabochon System for Improvement in the Appearance of Cellulite

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System for the improvement in the appearance of cellulite.

Official Title
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Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite

Conditions
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Gynoid Lipodystrophy

Intervention / Treatment
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* Device: Subcutaneous tissue release with the Cabochon System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, age 18-55 moderate or severe cellulite BMI less than 35 will not to try any other cellulite treatments through 12M follow-up Exclusion Criteria: cellulite treatment on the thighs or buttocks in the last 90 days prior liposuction in the thighs or buttocks Greater than 10% increase or decrease in body weight within past 6 months evidence of active infection or a fever >38C current or recent smoker history of hypertension, diabetes or hypoglycemia history of coagulopathy(ies) and/or on anticoagulant medication history of cardiopathy or pneumopathy history of severe anemia has atrophic scars, or has a history of atrophic scars or keloids taken within 14 days of treatment: NSAIDs (e.g. aspirin, ibuprofen, naproxen) Vitamin E, dietary supplements (e.g. Gingko Biloba, willow bark) Herbal Teas Subject is pregnant or lactating For Extended Follow-Up the following apply: Inclusion Criteria: Subject was enrolled and treated in the CP-01-1004 study - Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite Subject understands and accepts the obligation not to try or receive any other cellulite treatments through 3 year follow-up Exclusion Criteria: Subject has undergone an injected drug, energy-based device, minimally-invasive or invasive procedure for contouring or cellulite on the buttocks or thighs since their 12 month study follow-up visit. Subject has used skin care products (e.g. creams) for improvement in cellulite within 1 month prior to the follow-up visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Subcutaneous tissue release<br>Device: Subcutaneous tissue release with the Cabochon System | Device: Subcutaneous tissue release with the Cabochon System<br>* Device: Subcutaneous tissue release<br>* Other names: Cellfina®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change (Decrease) in Cellulite Severity | Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 and 5 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 3 and 5 years after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 3 and 5 years for the study population which was a minimum of 1 point lower than the baseline severity. | Treatment to 3 and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Cellulite Severity Grade | Percentage of subjects which were scored to have improvement of one grade or more in a 4 point Severity Grade (none, mild, moderate, severe) as determined by independent blinded physician assessment of subject photographs taken before and 3 and 5 years after treatment. | 3 and 5 years | 
| Improved Appearance | Improvement in subject's cellulite appearance according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician panel assessment of subject photographs taken before and 3 and 5 years after treatment. Change in the cellulite severity was rated according to 5 measures: Very much improved: Optimal cosmetic result in the treated areas for this subject Much improved: Marked or significant improvement in appearance of the treated areas from the initial condition Improved: Noticeable improvement in appearance of the treated areas from the initial condition but more subtle in magnitude No Change: The appearance of the treated areas is essentially the same as the original condition Worse: The appearance of the treated areas is worse than the original condition | Treatment to 3 and 5 years | 
| Subject Satisfaction | Subject rated satisfaction according to a 5 point Likert scale after treatment: Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied | Treatment to 3 and 5 years | 
| Procedure Tolerability | Subject rated pain according to a 0-10 numerical rating scale. Pain scale ranges from 0 (no pain) to 10 (worst possible pain). Measure was reported as mean and standard deviation of the pain score | Treatment to 3 and 5 years | 
| Safe Treatment | Freedom from serious adverse events directly attributable to the Cabochon System or procedure. | Treatment to 3 and 5 years |