Overview

This trial is active, not recruiting.

Condition gynoid lipodystrophy
Treatment subcutaneous tissue release with the cabochon system
Sponsor Cabochon Aesthetics, Inc.
Start date August 2012
End date November 2013
Trial size 55 participants
Trial identifier NCT01671839, CP-01-1004

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Device: Subcutaneous tissue release with the Cabochon System
subcutaneous tissue release with the cabochon system
Device: Subcutaneous tissue release

Primary Outcomes

Measure
Change in cellulite severity
time frame: Treatment to 1 year

Secondary Outcomes

Measure
Safe Treatment
time frame: Treatment to 1 year
Improved Appearance
time frame: Treatment to 1 year
Subject satisfaction
time frame: Treatment to 1 year
Procedure Tolerability
time frame: Treatment to 1 year

Eligibility Criteria

Female participants from 18 years up to 55 years old.

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

Additional Information

Official title Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite
Principal investigator Michael S Kaminer
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Cabochon Aesthetics, Inc..