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

Merz Pharmaceuticals

Status

Completed

Conditions

Gynoid Lipodystrophy

Treatments

Device: Subcutaneous tissue release with the Cabochon System

Study type

Interventional

Funder types

Industry

Identifiers

CP-01-1004

Details and patient eligibility

About

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

Enrollment

55 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.