An Open Label Study of Participants with Moderate or Severe Cellulite to Evaluate Focal Balloon Contouring.
- Conditions
- CelluliteSkin - Other skin conditions
- Registration Number
- ACTRN12618001911280
- Lead Sponsor
- C8 Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 9
* Moderate or severe cellulite in the thighs and/or buttocks
* BMI less than 30
* Caucasian
* Fluency in both written and spoken English
* Negative urine pregnancy test
* Will not try any other cellulite procedures through the follow-up period
* Cellulite procedure on the thighs or buttocks in the last 12 months
* Prior liposuction in the thighs or buttocks
* Greater than 10% increase or decrease in body weight within the last six months or history of greater than 60 kilograms weight loss
* Evidence of an active infection or fever greater than 38oC
* Current or recent smoker (within 6 months)
* History of hypertension, diabetes or hypoglycaemia
* Non-Caucasian
* Pregnant or breast feeding
* History of coagulopathy(ies) or pneumopathy
* History of severe anaemia
* Has atrophic scars, or a history of atrophic scars or keloids
* Taken within 14 days of procedure:
a. NSAIDs (e.g., aspirin, ibuprofen, naproxen)
b. Vitamin E, herbal teas or dietary supplements (e.g., Gingko Biloba, Willow Bark)
* Any known factor, condition or disease that in the opinion of the physician might interfere with procedure compliance, study conduct or interpretation of the results such as skin laxity, co-existent psychiatric disease, history of noncompliance to medical regimens, or unwillingness to comply with study requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of the Focal Balloon Contouring System determined by the absence of serious adverse device effects during the study. The data will be collected as reported by the patient and medical records. [Data will be collected at all patient visits including Procedure through to Day 90 (3 month) post procedure follow up visit. ]
- Secondary Outcome Measures
Name Time Method Feasibility (percentage of participants the procedure produces an effect).[Determined by the percentage of participants having a reduction in the appearance of their cellulite in the procedure area according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician assessment of participant photographs taken pre-operatively, 30 days and 90 days after procedure, with the secondary endpoint considered reached if greater than 50% of participants have an improvement by the GAIS at 90 days.]