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OpenTrials
Completed

NCT Number: NCT04743635

CONtrolled Focal Fibrous Band Release Method Study

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

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Key information

Conditions

Cellulite Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

21 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Site #7, Southport, Queensland, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate to severe cellulite

Exclusion criteria

  • Body Mass Index ≥30.0

Treatment and study plan

Avéli device

Device

Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.

Primary outcomes

  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

    • 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)

Secondary outcomes

  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

    • 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)

  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.

Sponsors and collaborators

Lead sponsor

Revelle Aesthetics, Inc

Industry

Registry information

Acronym: CONFFIRM

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 8, 2021
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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