None listed
Conditions
Brief summary
A clinical research study to evaluate focal balloon contouring to determine whether it is safe and may be effective in reducing the appearance of moderate or severe cellulite on the thighs and buttocks.
Interventions
The Focal Balloon Contouring system consists of a set of tools to evaluate a new procedure called Focal Balloon Contouring to determine whether it is safe and may be effective in reducing the appearance of moderate or severe cellulite on the thighs and buttocks. This procedure, lasting approximately 60 - 90 minutes, will be done by a plastic surgeon or surgical dermatologist in their clinic. After local anaesthetic has been applied to the intended area, this experimental procedure/intervention
The Focal Balloon Contouring system consists of a set of tools to evaluate a new procedure called Focal Balloon Contouring to determine whether it is safe and may be effective in reducing the appearance of moderate or severe cellulite on the thighs and buttocks. This procedure, lasting approximately 60 - 90 minutes, will be done by a plastic surgeon or surgical dermatologist in their clinic. After local anaesthetic has been applied to the intended area, this experimental procedure/intervention involves a small opening (less than 1cm) made in the skin at the intended procedural area of mid-thigh/buttock, and inserting a small balloon just under the skin which is then inflated to stretch and release this connective tissue support system of the fat, or fibrous septa. By doing this to areas of cellulite it is hoped that a visual change may occur which could potentially improve the overall impression of cellulite areas. This improvement could be seen as “contouring” an area and occurs at one visit with one side being treated. The side to be treated is at the discretion of the treating doctor.
Sponsors
NC8 Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Outcome results
None listed