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

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

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

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.