N/A
N=74
CONtrolled Focal Fibrous Band Release Method Study
Cellulite
Bottom Line
View on ClinicalTrials.gov: NCT04743635 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants — 1.5 score on a scale — p=.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Avéli device (Device)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Revelle Aesthetics, Inc
- Primary completion
- Jun 2021
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 | — |
Summary
Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.
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.