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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04743635
Registration number
NCT04743635
Ethics application status
Date submitted
3/02/2021
Date registered
8/02/2021
Date last updated
6/06/2023
Titles & IDs
Public title
CONtrolled Focal Fibrous Band Release Method Study
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Scientific title
CONtrolled Focal Fibrous Band Release Method Study
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Secondary ID [1]
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CP-10472
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Universal Trial Number (UTN)
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Trial acronym
CONFFIRM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cellulite
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Condition category
Condition code
Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Avéli device
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
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
Treatment: Devices: Avéli device
Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants
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Assessment method [1]
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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)
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Timepoint [1]
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3 months
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Secondary outcome [1]
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Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months
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Assessment method [1]
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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.
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Timepoint [1]
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3 months
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Secondary outcome [2]
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Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months
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Assessment method [2]
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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.
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Timepoint [2]
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12 Months
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Secondary outcome [3]
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The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants
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Assessment method [3]
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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)
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Timepoint [3]
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12 months
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Secondary outcome [4]
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The Percentage of Patients Satisfied With Their Results at 3 Months
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Assessment method [4]
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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.
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Timepoint [4]
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3 month
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Secondary outcome [5]
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The Number of Patients Satisfied With Their Results at 12 Months
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Assessment method [5]
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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.
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Timepoint [5]
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12 Months
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Eligibility
Key inclusion criteria
- Moderate to severe cellulite
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Minimum age
21
Years
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Maximum age
55
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Body Mass Index =30.0
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/01/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/03/2022
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Sample size
Target
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Accrual to date
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Final
74
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Clinical Site #7 - Southport
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Recruitment hospital [2]
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Clinical Site #9 - Toowoomba
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Recruitment postcode(s) [1]
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4215 - Southport
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Recruitment postcode(s) [2]
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4350 - Toowoomba
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Louisiana
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Country [4]
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United States of America
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State/province [4]
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Massachusetts
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Country [5]
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United States of America
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State/province [5]
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Minnesota
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Revelle Aesthetics, Inc
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the
appearance of cellulite.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04743635
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr. G. William Stevens, MD
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Address
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Marina Plastic Surgery
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04743635
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