CONtrolled Focal Fibrous Band Release Method Study

Cellulite Clinical Trial

— CONFFIRM  

Official title:

CONtrolled Focal Fibrous Band Release Method Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04743635
• Other study ID #: CP-10472
• Status: Completed
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: March 4, 2022

Study information

• Verified date: June 2022
• Source: Revelle Aesthetics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 4, 2022
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Moderate to severe cellulite

Exclusion Criteria:

• Body Mass Index =30.0

Related Conditions & MeSH terms

• Cellulite

Intervention

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

Locations

Country	Name	City	State
Australia	Clinical Site #7	Southport	Queensland
Australia	Clinical Site #9	Toowoomba	Queensland
United States	Clinical Site #8	Chestnut Hill	Massachusetts
United States	Clinical Site #2	Coral Gables	Florida
United States	Clinical Site #3	Los Angeles	California
United States	Clinical Site #1	Minneapolis	Minnesota
United States	Clinical Site #5	San Diego	California
United States	Clinical Site #4	San Francisco	California
United States	Clinical Site #6	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Revelle Aesthetics, Inc

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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