Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.
Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli device in reducing the appearance of cellulite.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.
Clinical Site #3
Los Angeles, California, United States
Clinical Site #5
San Diego, California, United States
Clinical Site #4
San Francisco, California, United States
Clinical Site #2
Coral Gables, Florida, United States
The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants
The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment. CSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1 PART A- Number of evident depressions 0 None 1. Mild (≤4 depressions) 2. Moderate (5 to 9 depressions) 3. Severe (≥ 10 depressions) PART B - Average depth of depressions 0 None 1. Mild (1-2 mm) 2. Moderate (3-4 mm) 3. Severe (≥5 mm)
Time frame: 3 months
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months
The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3). The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6. Scale: -3:very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas.
Time frame: 3 months
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months
The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3). Scale: -3: very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas.
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Clinical Site #6
Shreveport, Louisiana, United States
Clinical Site #8
Chestnut Hill, Massachusetts, United States
Clinical Site #1
Minneapolis, Minnesota, United States
Clinical Site #7
Southport, Queensland, Australia
Clinical Site #9
Toowoomba, Queensland, Australia
Time frame: 12 Months
The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants
The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment. CSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1 PART A- Number of evident depressions 0 None 1. Mild (≤4 depressions) 2. Moderate (5 to 9 depressions) 3. Severe (≥ 10 depressions) PART B - Average depth of depressions 0 None 1. Mild (1-2 mm) 2. Moderate (3-4 mm) 3. Severe (≥5 mm)
Time frame: 12 months
The Percentage of Patients Satisfied With Their Results at 3 Months
Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 3 months. The outcome measure reports the percentage of participants satisfied with their results at 3 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses. The lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6.
Time frame: 3 month
The Number of Patients Satisfied With Their Results at 12 Months
Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 12 months. The outcome measure reports the number of participants satisfied with their results at 12 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses.
Time frame: 12 Months