Adults 21 to 55, female only, with Cellulite. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for ParticipantsPrimary· 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)
Group
Value
95% CI
Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT
1.5
± 0.9
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 MonthsSecondary· 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 be
Group
Value
95% CI
Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT
95.6
87.6 – 99.1
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 MonthsSecondary· 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 treat
Group
Value
95% CI
Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT
93.85
84.99 – 98.30
The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for ParticipantsSecondary· 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)
Group
Value
95% CI
Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT
1.48
± 0.87
The Percentage of Patients Satisfied With Their Results at 3 MonthsSecondary· 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.
Group
Value
95% CI
Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT
72.1
59.9 – 82.3
The Number of Patients Satisfied With Their Results at 12 MonthsSecondary· 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.
Group
Value
95% CI
Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT
45
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT
Serious: 0/68 (0%)
Deaths: 0/68
Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in
NCT06791564 — Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in B
· NA
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Revelle Aesthetics, Inc
Last refreshed: 6 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04743635.