CONtrolled Focal Fibrous Band Release Method Study

Not Applicable

Completed

Conditions: Cellulite

Interventions: Device: Avéli device

Registration Number: NCT04743635

Lead Sponsor: Revelle Aesthetics, Inc

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

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 74

Inclusion Criteria

Moderate to severe cellulite

Exclusion Criteria

Body Mass Index ≥30.0

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Targeted Verifiable Subcision (TVS) with the Avéli device, mITT	Avéli device	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
Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-in	Avéli device	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

Primary Outcome Measures

Name	Time	Method
The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants	3 months	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)

Secondary Outcome Measures

Name	Time	Method
The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants	12 months	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)
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months	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.
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months	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.
The Percentage of Patients Satisfied With Their Results at 3 Months	3 month	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.
The Number of Patients Satisfied With Their Results at 12 Months	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.

Trial Locations

Locations (9): Clinical Site #5
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San Diego, California, United States
Clinical Site #3
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Los Angeles, California, United States
Clinical Site #4
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San Francisco, California, United States
Clinical Site #2
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Coral Gables, Florida, United States
Clinical Site #1
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Minneapolis, Minnesota, United States
Clinical Site #6
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Shreveport, Louisiana, United States
Clinical Site #7
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Southport, Queensland, Australia
Clinical Site #8
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Chestnut Hill, Massachusetts, United States
Clinical Site #9
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Toowoomba, Queensland, Australia