None listed
Conditions
Brief summary
This is a prospective, pilot trial with two study groups. Group 1 will undergo cellulite treatment on their thighs with optional buttock treatment with the Avéli device. Group 2 will undergo the combined procedure of Avéli treatment for cellulite with fat grafting on their thighs with optional buttock treatment.
Interventions
Group 1 participants will undergo treatment on their thighs with optional buttock treatment with the Avéli procedure. Group 2 participants will undergo a combined procedure of Avéli with small volume fat grafting. The Avéli precision cellulite release device is a manual instrument intended to separate tissue (manner for the reduction in the appearance of cellulite). The Investigator will allocate participants to Group 1 or group 2 per the inclusion/exclusion criteria. Any candidates enrolled in
Group 1 participants will undergo treatment on their thighs with optional buttock treatment with the Avéli procedure. Group 2 participants will undergo a combined procedure of Avéli with small volume fat grafting. The Avéli precision cellulite release device is a manual instrument intended to separate tissue (manner for the reduction in the appearance of cellulite). The Investigator will allocate participants to Group 1 or group 2 per the inclusion/exclusion criteria. Any candidates enrolled in Group 2 must have a suitable fat donor site. A minimum of 5 participants must be enrolled in each group.
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
No
Inclusion criteria
1.Female 21-55 years 2.Moderate to severe cellulite on the thighs, or, if applicable buttocks 3.Minimum of 5 depressions on the thigh(s) 4.BMI < 35
Exclusion criteria
1.In the last 12 months, underwent a cellulite treatment on the buttocks and/or thighs 2.Previous liposuction on the buttocks and/or thighs 3.Greater than 10% increase or decrease in body weight within the last six (6) months or any history of weight loss greater than 60 kg 4.Tattoo or former tattoo in the treatment area 5.Physician assessed severe skin laxity, flaccidity, and/or sagging in targeted cellulite treatment regions
Outcome results
None listed