Cellulite
Conditions
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.
Interventions
DEVICEAvéli device
Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.
Sponsors
Revelle Aesthetics, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants were treated with the Avéli device.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Moderate to severe cellulite
Exclusion criteria
* Body Mass Index ≥30.0
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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) |
| 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. |
Countries
Australia, United States
Participant flow
Pre-assignment details
74 was total enrollment: * 68 participants allocated to Targeted Verifiable Subcision (TVS) with the Avéli device, mITT * 6 participants allocated to Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-Ins. 6 training participants for 3 new Investigators.
Participants by arm
| Arm | Count |
|---|---|
| Targeted Verifiable Subcision (TVS) With the Avéli Device Modified intent to treat population (mITT), n=68. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite. | 68 |
| Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in Roll-in participants, n=6. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite. | 6 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in | Targeted Verifiable Subcision (TVS) With the Avéli Device | Total |
|---|---|---|---|
| Age, Continuous | 40.8 years STANDARD_DEVIATION 8.1 | 41.5 years STANDARD_DEVIATION 7.4 | 41.5 years STANDARD_DEVIATION 7.3 |
| BMI | 23.1 kg/m^2 STANDARD_DEVIATION 3.6 | 24.9 kg/m^2 STANDARD_DEVIATION 2.6 | 24.8 kg/m^2 STANDARD_DEVIATION 2.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 19 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 49 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type I | 2 Participants | 1 Participants | 3 Participants |
| Fitzpatrick Skin Type II | 1 Participants | 19 Participants | 20 Participants |
| Fitzpatrick Skin Type III | 2 Participants | 24 Participants | 26 Participants |
| Fitzpatrick Skin Type IV | 1 Participants | 15 Participants | 16 Participants |
| Fitzpatrick Skin Type V | 0 Participants | 6 Participants | 6 Participants |
| Fitzpatrick Skin Type VI | 0 Participants | 3 Participants | 3 Participants |
| Laxity Mild | 3 Participants | 37 Participants | 40 Participants |
| Laxity Moderate | 3 Participants | 30 Participants | 33 Participants |
| Laxity None | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 6 Participants | 54 Participants | 60 Participants |
| Region of Enrollment Australia | 0 participants | 16 participants | 16 participants |
| Region of Enrollment United States | 6 participants | 52 participants | 58 participants |
| Sex: Female, Male Female | 6 Participants | 68 Participants | 74 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 6 |
| other Total, other adverse events | 68 / 68 | 6 / 6 |
| serious Total, serious adverse events | 0 / 68 | 0 / 6 |
Outcome results
Primary
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
Population: mITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT | The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants | 1.5 score on a scale | Standard Deviation 0.9 |
Comparison: The endpoint tested the mean of the changes for each treated participant, not a 1-point change between mean score of the group at baseline versus 3 months. Success is achieved when the mean change across all treated participants is at least one point.p-value: 0.000195% CI: [1.28, 1.71]t-test, 2 sided
Secondary
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.
Time frame: 12 Months
Population: mITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT | Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months | 93.85 percentage of participants |
Secondary
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
Population: mITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT | Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months | 95.6 Percentage of participants |
Comparison: The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted (e.g., if improved, worse and much worse, worse was counted). A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3).p-value: 0.000195% CI: [87.6, 99.1]t-test, 2 sided
Secondary
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
Population: mITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT | The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants | 1.48 score on a scale | Standard Deviation 0.87 |
Secondary
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
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT | The Number of Patients Satisfied With Their Results at 12 Months | 45 Participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT | The Percentage of Patients Satisfied With Their Results at 3 Months | 72.1 percentage of participants |
p-value: 0.026495% CI: [59.9, 82.3]t-test, 2 sided