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CONtrolled Focal Fibrous Band Release Method Study (CONFFIRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04743635
Recruitment Status : Completed
First Posted : February 8, 2021
Results First Posted : June 6, 2023
Last Update Posted : June 6, 2023
Sponsor:
Information provided by (Responsible Party):
Revelle Aesthetics, Inc

Study Description
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Brief Summary:
Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.

Condition or disease Intervention/treatment Phase
Cellulite Device: Avéli device Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: All participants were treated with the Avéli device.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CONtrolled Focal Fibrous Band Release Method Study
Actual Study Start Date : January 7, 2021
Actual Primary Completion Date : June 14, 2021
Actual Study Completion Date : March 4, 2022
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants [ Time Frame: 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)


Secondary Outcome Measures :
  1. Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months [ Time Frame: 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.


  2. Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months [ Time Frame: 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.


  3. The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants [ Time Frame: 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)

  4. The Percentage of Patients Satisfied With Their Results at 3 Months [ Time Frame: 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.


  5. The Number of Patients Satisfied With Their Results at 12 Months [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Moderate to severe cellulite

Exclusion Criteria:

  • Body Mass Index ≥30.0
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743635


Locations
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United States, California
Clinical Site #3
Los Angeles, California, United States, 90292
Clinical Site #5
San Diego, California, United States, 92121
Clinical Site #4
San Francisco, California, United States, 94102
United States, Florida
Clinical Site #2
Coral Gables, Florida, United States, 33146
United States, Louisiana
Clinical Site #6
Shreveport, Louisiana, United States, 71105
United States, Massachusetts
Clinical Site #8
Chestnut Hill, Massachusetts, United States, 02467
United States, Minnesota
Clinical Site #1
Minneapolis, Minnesota, United States, 55441
Australia, Queensland
Clinical Site #7
Southport, Queensland, Australia, 4215
Clinical Site #9
Toowoomba, Queensland, Australia, 4350
Sponsors and Collaborators
Revelle Aesthetics, Inc
Investigators
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Principal Investigator: Dr. G. William Stevens, MD Marina Plastic Surgery
  Study Documents (Full-Text)

Documents provided by Revelle Aesthetics, Inc:
Study Protocol and Statistical Analysis Plan  [PDF] April 29, 2021

More Information
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Responsible Party: Revelle Aesthetics, Inc
ClinicalTrials.gov Identifier: NCT04743635    
Other Study ID Numbers: CP-10472
First Posted: February 8, 2021    Key Record Dates
Results First Posted: June 6, 2023
Last Update Posted: June 6, 2023
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to share Executive Summary of Protocol. No formal, separate SAP for this study.
Supporting Materials: Study Protocol
Time Frame: Will post Protocol Executive Summary on June 14, 2022. It will be available indefinitely.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Cellulite
Skin Manifestations