Trial Outcomes & Findings for Study of the Cabochon System for Improvement in the Appearance of Cellulite (NCT NCT01671839)
NCT ID: NCT01671839
Last Updated: 2019-12-10
Results Overview
Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 and 5 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 3 and 5 years after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 3 and 5 years for the study population which was a minimum of 1 point lower than the baseline severity.
COMPLETED
NA
55 participants
Treatment to 3 and 5 years
2019-12-10
Participant Flow
Participant milestones
| Measure |
Subcutaneous Tissue Release
Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
3-year Follow-up
|
45
|
|
Overall Study
5-year Follow-up
|
37
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Cabochon System for Improvement in the Appearance of Cellulite
Baseline characteristics by cohort
| Measure |
Subcutaneous Tissue Release
n=55 Participants
Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release
|
|---|---|
|
Age, Continuous
|
40.7 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment to 3 and 5 yearsPopulation: The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing primary and powered secondary endpoint outcomes.
Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 and 5 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 3 and 5 years after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 3 and 5 years for the study population which was a minimum of 1 point lower than the baseline severity.
Outcome measures
| Measure |
Subcutaneous Tissue Release - 3 Years
n=45 Participants
Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release
|
Subcutaneous Tissue Release - 5 Years
|
|---|---|---|
|
Mean Change (Decrease) in Cellulite Severity
3 years
|
2.0 units on a scale
Interval 1.7 to 2.3
|
—
|
|
Mean Change (Decrease) in Cellulite Severity
5 years
|
1.8 units on a scale
Interval 1.4 to 2.2
|
—
|
SECONDARY outcome
Timeframe: 3 and 5 yearsPopulation: The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing endpoint outcomes.
Percentage of subjects which were scored to have improvement of one grade or more in a 4 point Severity Grade (none, mild, moderate, severe) as determined by independent blinded physician assessment of subject photographs taken before and 3 and 5 years after treatment.
Outcome measures
| Measure |
Subcutaneous Tissue Release - 3 Years
n=45 Participants
Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release
|
Subcutaneous Tissue Release - 5 Years
|
|---|---|---|
|
Improvement in Cellulite Severity Grade
3 years
|
91.1 percentage of subjects
Interval 79.3 to 100.0
|
—
|
|
Improvement in Cellulite Severity Grade
5 years
|
86 percentage of subjects
Interval 75.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Treatment to 3 and 5 yearsPopulation: The primary analysis was based upon the complete case population (CC).
Improvement in subject's cellulite appearance according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician panel assessment of subject photographs taken before and 3 and 5 years after treatment. Change in the cellulite severity was rated according to 5 measures: * Very much improved: Optimal cosmetic result in the treated areas for this subject * Much improved: Marked or significant improvement in appearance of the treated areas from the initial condition * Improved: Noticeable improvement in appearance of the treated areas from the initial condition but more subtle in magnitude * No Change: The appearance of the treated areas is essentially the same as the original condition * Worse: The appearance of the treated areas is worse than the original condition
Outcome measures
| Measure |
Subcutaneous Tissue Release - 3 Years
n=45 Participants
Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release
|
Subcutaneous Tissue Release - 5 Years
n=37 Participants
|
|---|---|---|
|
Improved Appearance
Much Improved
|
46.7 percentage of subjects
Interval 31.7 to 62.1
|
29.7 percentage of subjects
Interval 15.9 to 47.0
|
|
Improved Appearance
Improved
|
44.4 percentage of subjects
Interval 29.6 to 60.0
|
64.9 percentage of subjects
Interval 47.5 to 79.8
|
|
Improved Appearance
No Change
|
0 percentage of subjects
Interval 0.0 to 6.9
|
0 percentage of subjects
Interval 0.0 to 9.5
|
|
Improved Appearance
Very Much Improved
|
8.9 percentage of subjects
Interval 2.5 to 21.2
|
5.4 percentage of subjects
Interval 0.7 to 18.2
|
|
Improved Appearance
Worse
|
0 percentage of subjects
Interval 0.0 to 6.9
|
0 percentage of subjects
Interval 0.0 to 9.5
|
SECONDARY outcome
Timeframe: Treatment to 3 and 5 yearsPopulation: The primary analysis was based upon the complete case population (CC).
Subject rated satisfaction according to a 5 point Likert scale after treatment: Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied
Outcome measures
| Measure |
Subcutaneous Tissue Release - 3 Years
n=45 Participants
Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release
|
Subcutaneous Tissue Release - 5 Years
n=37 Participants
|
|---|---|---|
|
Subject Satisfaction
% Very Satisfied
|
42.2 percentage of subjects
Interval 27.7 to 57.9
|
46.0 percentage of subjects
Interval 29.5 to 63.1
|
|
Subject Satisfaction
% Satisfied
|
51.1 percentage of subjects
Interval 35.8 to 66.3
|
32.4 percentage of subjects
Interval 18.0 to 49.8
|
|
Subject Satisfaction
% Neutral
|
6.7 percentage of subjects
Interval 1.4 to 18.3
|
18.9 percentage of subjects
Interval 8.0 to 35.2
|
|
Subject Satisfaction
% Unsatisfied
|
0 percentage of subjects
Interval 0.0 to 6.8
|
0 percentage of subjects
Interval 0.0 to 9.5
|
|
Subject Satisfaction
% Very Unsatisfied
|
0 percentage of subjects
Interval 0.0 to 6.8
|
0 percentage of subjects
Interval 0.0 to 9.5
|
SECONDARY outcome
Timeframe: Treatment to 3 and 5 yearsPopulation: The primary analysis was based upon the complete case population (CC).
Subject rated pain according to a 0-10 numerical rating scale. Pain scale ranges from 0 (no pain) to 10 (worst possible pain). Measure was reported as mean and standard deviation of the pain score
Outcome measures
| Measure |
Subcutaneous Tissue Release - 3 Years
n=45 Participants
Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release
|
Subcutaneous Tissue Release - 5 Years
n=37 Participants
|
|---|---|---|
|
Procedure Tolerability
|
0 units on scale
Standard Deviation 0
|
0 units on scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Treatment to 3 and 5 yearsFreedom from serious adverse events directly attributable to the Cabochon System or procedure.
Outcome measures
| Measure |
Subcutaneous Tissue Release - 3 Years
n=45 Participants
Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release
|
Subcutaneous Tissue Release - 5 Years
n=37 Participants
|
|---|---|---|
|
Safe Treatment
|
0 occurence of serious adverse events
|
0 occurence of serious adverse events
|
Adverse Events
Subcutaneous Tissue Release - 3 Years
Subcutaneous Tissue Release - Years 4-5
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subcutaneous Tissue Release - 3 Years
n=55 participants at risk
Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release
|
Subcutaneous Tissue Release - Years 4-5
n=37 participants at risk
|
|---|---|---|
|
Infections and infestations
Cold
|
3.6%
2/55 • From baseline up to year 5.
|
0.00%
0/37 • From baseline up to year 5.
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
2/55 • From baseline up to year 5.
|
0.00%
0/37 • From baseline up to year 5.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
3.6%
2/55 • From baseline up to year 5.
|
0.00%
0/37 • From baseline up to year 5.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator agrees that the first publication of the results shall be made in conjunction with the results from all study centers. If Investigator desires independently to publish information about data obtained at Investigator's facility, then Investigator may do so, provided a copy of any proposed oral presentation or written publication is received by Company at least 45 days in advance of submission for publication.
- Publication restrictions are in place
Restriction type: OTHER