None listed
Conditions
Brief summary
A prospective study to evaluate the Focal Contouring System to determine whether it is safe and efficacious in reducing the appearance of moderate or severe cellulite on the thighs and buttocks.
Interventions
The Focal Contouring system consists of a set of tools to access and release septa associated with cellulite. This new procedure, called Focal Contouring, is being done 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 a
The Focal Contouring system consists of a set of tools to access and release septa associated with cellulite. This new procedure, called Focal Contouring, is being done 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 incision (less than 1cm) in the skin at the intended procedural area of mid-thigh/buttock. The deployable hook is introduced through the skin and then guided to the targeted area with the assistance of the light fibre which will illuminate under the skin. The hook is then hooked around the fibrous septa where tension is then applied to release the 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. The side to be treated is at the discretion of the treating doctor.
Sponsors
Revelle Aesthetics 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
1. Moderate (depressions appear spontaneously when standing and not lying down) or severe (depressions appear spontaneously when standing and lying down) cellulite in the thighs and/or buttocks 2. BMI less than 30 3. Caucasian 4. Fluency in both written and spoken English 5. Negative urine pregnancy test 6. Will not try any other cellulite procedures through the follow-up period 7. Participants of the previously conducted Contour-0001 study will be permitted to be enrolled provided they have exited the Contour-0001 study already.
Exclusion criteria
1. Contour-0001 or Contour-0002 cellulite procedure on the thighs or buttocks in the last 3 months 2. Any non-Contour System procedure on thighs or buttocks to treat cellulite (for example, Cellfina) 3. Prior liposuction in the thighs or buttocks 4. Greater than 10% increase or decrease in body weight within the last six months or history of greater than 60 kilograms weight loss 5. Evidence of an active infection or fever greater than 38oC 6. Current or recent smoker (within 6 months) 7. History of hypertension, diabetes or hypoglycemia 8. Non-Caucasian 9. Pregnant or breast feeding 10. History of coagulopathy(ies) or pneumopathy 11. History of severe anemia 12. Has atrophic scars, or a history of atrophic scars or keloids 13. 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) 14. 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