An interventional study of Avéli device in Cellulite, sponsored by Revelle Aesthetics, Inc. Completed at 9 sites in 2 countries. Open to female participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-06.
Sponsored by Revelle Aesthetics, Inc · Not applicable, Interventional, and Treatment
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.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 74 is above the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →This is the only study on the registry with Revelle Aesthetics, Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.
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.
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
| Milestone | Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in |
|---|---|---|
| Started | 68 | 6 |
| Completed | 66 | 6 |
| Not completed | 2 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
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)
| score on a scale | 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 ± 0.9 |
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 | 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 (87.6 to 99.1) |
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.
| percentage of participants | 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 (84.99 to 98.30) |
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)
| score on a scale | 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 ± 0.87 |
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.
| percentage of participants | Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT |
|---|---|
| The Percentage of Patients Satisfied With Their Results at 3 Months | 72.1 (59.9 to 82.3) |
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.
| Participants | Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT |
|---|---|
| The Number of Patients Satisfied With Their Results at 12 Months | 45 |
Collected over 1 year. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT | 0/68 (0%) | 0/68 (0%) | 68/68 (100%) |
| Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Event | Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in |
|---|---|---|
| EcchymosisSkin and subcutaneous tissue disorders | 59/68 | 6/6 |
| TendernessGeneral disorders | 35/68 | 3/6 |
| PainGeneral disorders | 26/68 | 2/6 |
| IndurationGeneral disorders | 25/68 | 2/6 |
| NumbnessNervous system disorders | 12/68 | 0/6 |
| EdemaGeneral disorders | 8/68 | 1/6 |
| Contact DermatitisSkin and subcutaneous tissue disorders | 0/68 | 1/6 |
| Incision site bleedingGeneral disorders | 11/68 | 0/6 |
| Fluid DischargeGeneral disorders | 6/68 | 0/6 |
| Hemosiderin stainSkin and subcutaneous tissue disorders | 5/68 | 0/6 |
| Age, Continuous(years) | Targeted Verifiable Subcision (TVS) With the Avéli Device | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in | Total |
|---|---|---|---|
| Mean | 41.5 ± 7.4 | 40.8 ± 8.1 | 41.5 ± 7.3 |
| Sex: Female, Male(Participants) | Targeted Verifiable Subcision (TVS) With the Avéli Device | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in | Total |
|---|---|---|---|
| Female | 68 | 6 | 74 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Targeted Verifiable Subcision (TVS) With the Avéli Device | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in | Total |
|---|---|---|---|
| Hispanic or Latino | 19 | 2 | 21 |
| Not Hispanic or Latino | 49 | 4 | 53 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Targeted Verifiable Subcision (TVS) With the Avéli Device | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 6 | 0 | 6 |
| White | 54 | 6 | 60 |
| More than one race | 3 | 0 | 3 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Region of Enrollment(participants) | Targeted Verifiable Subcision (TVS) With the Avéli Device | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in | Total |
|---|---|---|---|
| United States | 52 | 6 | 58 |
| Australia | 16 | 0 | 16 |
| Fitzpatrick Skin Type(Participants) | Targeted Verifiable Subcision (TVS) With the Avéli Device | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in | Total |
|---|---|---|---|
| I | 1 | 2 | 3 |
| II | 19 | 1 | 20 |
| III | 24 | 2 | 26 |
| IV | 15 | 1 | 16 |
| V | 6 | 0 | 6 |
| VI | 3 | 0 | 3 |
| BMI(kg/m^2) | Targeted Verifiable Subcision (TVS) With the Avéli Device | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in | Total |
|---|---|---|---|
| Mean | 24.9 ± 2.6 | 23.1 ± 3.6 | 24.8 ± 2.7 |
| Laxity(Participants) | Targeted Verifiable Subcision (TVS) With the Avéli Device | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in | Total |
|---|---|---|---|
| None | 1 | 0 | 1 |
| Mild | 37 | 3 | 40 |
| Moderate | 30 | 3 | 33 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Plan to share Executive Summary of Protocol. No formal, separate SAP for this study.
Supporting information: Study protocol
Time frame: Will post Protocol Executive Summary on June 14, 2022. It will be available indefinitely.
Ran from Jan 2021 to primary completion in Jun 2021, 5 months.
Results were first posted in Jun 2023, 1 year 11 months after primary completion.
Of 20 interventional studies with no phase under Cellulite, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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