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| Name | Class |
|---|---|
| Ulthera, Inc | INDUSTRY |
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The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System for the improvement in the appearance of cellulite.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous tissue release | Experimental | Device: Subcutaneous tissue release with the Cabochon System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous tissue release with the Cabochon System | Device | Device: Subcutaneous tissue release |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change (Decrease) in Cellulite Severity | 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. | Treatment to 3 and 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Cellulite Severity Grade | 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. | 3 and 5 years |
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Inclusion Criteria:
Exclusion Criteria:
cellulite treatment on the thighs or buttocks in the last 90 days
prior liposuction in the thighs or buttocks
Greater than 10% increase or decrease in body weight within past 6 months
evidence of active infection or a fever >38C
current or recent smoker
history of hypertension, diabetes or hypoglycemia
history of coagulopathy(ies) and/or on anticoagulant medication
history of cardiopathy or pneumopathy
history of severe anemia
has atrophic scars, or has a history of atrophic scars or keloids
taken within 14 days of treatment:
Subject is pregnant or lactating
For Extended Follow-Up the following apply:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Kaminer | Skin Care Physicians | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Coleman Center for Cosmetic and Dermatologic Surgery | Metairie | Louisiana | 70006 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Subcutaneous Tissue Release | Device: Subcutaneous tissue release with the Cabochon System Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subcutaneous Tissue Release | Device: Subcutaneous tissue release with the Cabochon System Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change (Decrease) in Cellulite Severity | 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Treatment to 3 and 5 years |
|
From baseline up to year 5.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subcutaneous Tissue Release - 3 Years | Device: Subcutaneous tissue release with the Cabochon System Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals | +49 69 1503 0 | clinicaltrials@merz.com |
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| Improved Appearance |
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:
|
| Treatment to 3 and 5 years |
| Subject Satisfaction | Subject rated satisfaction according to a 5 point Likert scale after treatment: Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied | Treatment to 3 and 5 years |
| Procedure Tolerability | 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 | Treatment to 3 and 5 years |
| Safe Treatment | Freedom from serious adverse events directly attributable to the Cabochon System or procedure. | Treatment to 3 and 5 years |
| Maryland Laser Skin & Vein Institute |
| Hunt Valley |
| Maryland |
| 21030 |
| United States |
| SkinCare Physicians | Chestnut Hill | Massachusetts | 02467 | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Subcutaneous Tissue Release |
Device: Subcutaneous tissue release with the Cabochon System Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release |
|
|
| Secondary | Improvement in Cellulite Severity Grade | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of subjects | 3 and 5 years |
|
|
|
| Secondary | Improved Appearance | 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:
| The primary analysis was based upon the complete case population (CC). | Posted | Number | 95% Confidence Interval | percentage of subjects | Treatment to 3 and 5 years |
|
|
|
| Secondary | Subject Satisfaction | Subject rated satisfaction according to a 5 point Likert scale after treatment: Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied | The primary analysis was based upon the complete case population (CC). | Posted | Number | 95% Confidence Interval | percentage of subjects | Treatment to 3 and 5 years |
|
|
|
| Secondary | Procedure Tolerability | 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 | The primary analysis was based upon the complete case population (CC). | Posted | Mean | Standard Deviation | units on scale | Treatment to 3 and 5 years |
|
|
|
| Secondary | Safe Treatment | Freedom from serious adverse events directly attributable to the Cabochon System or procedure. | Posted | Number | occurence of serious adverse events | Treatment to 3 and 5 years |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 4 |
| 55 |
| EG001 | Subcutaneous Tissue Release - Years 4-5 | 0 | 37 | 0 | 37 | 0 | 37 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Hypercholesterolemia | Metabolism and nutrition disorders | Systematic Assessment |
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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.
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| Improved |
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| No Change |
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| Worse |
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| % Neutral |
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| % Unsatisfied |
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| % Very Unsatisfied |
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