CONtrolled Focal Fibrous Band Release Method Study (CONFFIRM)

Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.

Study Overview

• Status: Completed
• Conditions: Cellulite
• Intervention / Treatment: Device: Avéli device

Detailed Description

Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli device in reducing the appearance of cellulite.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Southport, Queensland, Australia, 4215
      • Clinical Site #7
    • Toowoomba, Queensland, Australia, 4350
      • Clinical Site #9
• United States
  • California
    • Los Angeles, California, United States, 90292
      • Clinical Site #3
    • San Diego, California, United States, 92121
      • Clinical Site #5
    • San Francisco, California, United States, 94102
      • Clinical Site #4
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Clinical Site #2
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Clinical Site #6
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Clinical Site #8
  • Minnesota
    • Minneapolis, Minnesota, United States, 55441
      • Clinical Site #1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 51 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Moderate to severe cellulite

Exclusion Criteria:

• Body Mass Index ≥30.0

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Targeted Verifiable Subcision (TVS) with the Avéli device, mITT; 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; Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.
Experimental: Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-in; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; Mild (≤4 depressions); Moderate (5 to 9 depressions); Severe (≥ 10 depressions) PART B - Average depth of depressions 0 None; Mild (1-2 mm); Moderate (3-4 mm); Severe (≥5 mm)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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; Mild (≤4 depressions); Moderate (5 to 9 depressions); Severe (≥ 10 depressions) PART B - Average depth of depressions 0 None; Mild (1-2 mm); Moderate (3-4 mm); Severe (≥5 mm)	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.	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.	12 Months

Collaborators and Investigators

• Sponsor: Revelle Aesthetics, Inc
• Investigators: Principal Investigator: Dr. G. William Stevens, MD, Marina Plastic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Actual): June 14, 2021
• Study Completion (Actual): March 4, 2022

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Cellulite
• Other Study ID Numbers: CP-10472

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan to share Executive Summary of Protocol. No formal, separate SAP for this study.
• IPD Sharing Time Frame: Will post Protocol Executive Summary on June 14, 2022. It will be available indefinitely.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes