CONtrolled Focal Fibrous Band Release Method Study

Study Overview
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Brief Summary
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Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.

Detailed Description
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Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli device in reducing the appearance of cellulite.

Official Title
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CONtrolled Focal Fibrous Band Release Method Study

Conditions
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Cellulite

Intervention / Treatment
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* Device: Avéli device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe cellulite Exclusion Criteria: Body Mass Index ≥30.0

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All participants were treated with the Avéli device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted Verifiable Subcision (TVS) with the Avéli device, mITT<br>Modified intent to treat population (n=68). The modified intent to treat population was used to evaluate effectiveness. The single procedure was conducted using the Avéli device for TVS. Cellulite can be treated on the thighs and buttocks | Device: Avéli device<br>* Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.<br>|
| Experimental: Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-in<br>The roll-in population (n=6) was excluded from the effectiveness analyses. For Investigators that have not previously performed an Avéli procedure, two (2) participants were classified as roll-in participants. The single procedure was conducted using the Avéli device for TVS. Cellulite can be treated on the thighs and buttocks | Device: Avéli device<br>* Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Mild (≤4 depressions) Moderate (5 to 9 depressions) Severe (≥ 10 depressions) PART B - Average depth of depressions 0 None Mild (1-2 mm) Moderate (3-4 mm) Severe (≥5 mm) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 Mild (≤4 depressions) Moderate (5 to 9 depressions) Severe (≥ 10 depressions) PART B - Average depth of depressions 0 None Mild (1-2 mm) Moderate (3-4 mm) Severe (≥5 mm) | 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. | 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. | 12 Months |