N/A
Completed N=74
CONtrolled Focal Fibrous Band Release Method Study
Cellulite
Source: ClinicalTrials.gov NCT04743635 ↗
Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants — 1.5 score on a scale — p=.0001
Summary
Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants |
1.5 | .0001 sig |
| SECONDARY Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months |
95.6 | .0001 sig |
| SECONDARY Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months |
93.85 | — |
| SECONDARY The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants |
1.48 | — |
| SECONDARY The Percentage of Patients Satisfied With Their Results at 3 Months |
72.1 | .0264 sig |
| SECONDARY The Number of Patients Satisfied With Their Results at 12 Months |
45 | — |
Eligibility Criteria
Inclusion Criteria
- Moderate to severe cellulite
Exclusion Criteria
- Body Mass Index ≥30.0
Data sourced from ClinicalTrials.gov (NCT04743635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.