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This study is being performed to reduce unwanted abdominal fat using a new applicator for the Zeltiq System.
The primary objective of the study is to achieve a discernable change to the contour of the abdominal area treated with the JUNO applicator that is consistent with that documented during a clinical study of a previous applicator used to treat lovehandles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Abdomen Treatment Group | Experimental | All subjects were treated on the abdomen with the CoolSculpting system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Zeltiq System | Device | Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Pre-treatment Images Correctly Identified | Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. The expected success rate is an average 80% correct identification by the three reviewers. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Fat Layer of the Treated Area as Measured by Ultrasound | Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations. Results indicate the fat layer reduction in mm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser and Skin Surgery of Northern California | Sacramento | California | 95816 | United States | ||
| Flor Mayoral, M.D. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zeltiq System Treatment Group | The treatment group consists of all subjects treated with the Zeltiq System for the reduction of abdominal fat. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population included all subjects enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zeltiq System Treatment Group | The treatment group consists of all subjects treated with the Zeltiq System for the reduction of abdominal fat. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Proportion of Pre-treatment Images Correctly Identified | Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. The expected success rate is an average 80% correct identification by the three reviewers. | The per protocol population are those subjects who were treated with the Zeltiq CoolSculping System and maintained weight as specified in the protocol. | Posted | Count of Units | photos | 16 weeks | photos | photos |
|
Adverse event data were collected from the time of enrollment through the 16 week follow-up visit.
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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 | Zeltiq System Treatment Group | The treatment group consists of all subjects treated with the Zeltiq System for the reduction of abdominal fat. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kerrie Jiang, Executive Director Regulatory, Clinical and Medical Affairs | Zeltiq Aesthetics | (925) 621-7462 | kerrie.jiang@allergan.com |
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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
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| 16 weeks |
| Subject Satisfaction | Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. | 16 weeks |
| Coral Gables |
| Florida |
| 33143 |
| United States |
| Maryland Laser, Skin and Vein Institute | Hunt Valley | Maryland | 21030 | United States |
| Skin Care Physicians of Chestnut Hill | Chestnut Hill | Massachusetts | 02467 | United States |
| Zel Skin and Laser Specialist LLC | Edina | Minnesota | 55424 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fitzpatrick Skin Type | The Fitzpatrick Skin Type scale is a numerical classification schema for human skin color, developed as a way to estimate the response of different skin types of skin to ultraviolet (UV) light. Fitzpatrick skin type characteristics are present at birth. The scale is composed of six skin type classifications for FST I to FST VI. There is no additional value in the skin type scale, e.g., a FST VI classification is no more or less valuable than a classification of FST I, FST II, FST III, FST IV or FST V. | Count of Participants | Participants |
|
| Zeltiq System Treatment Group |
The per protocol population consists of all evaluable subjects treated with the Zeltiq System for the reduction of abdominal fat and whose weight change was within 5 pounds of baseline weight. |
|
|
|
| Secondary | Change in the Fat Layer of the Treated Area as Measured by Ultrasound | Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations. Results indicate the fat layer reduction in mm. | All subjects who completed treatment with the Zeltiq System, independent of weight changes, were included in the analysis population. | Posted | Mean | Standard Deviation | mm | 16 weeks |
|
|
|
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| Secondary | Subject Satisfaction | Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. | All evaluable subjects that completed the satisfaction questionnaire were included in the analysis. | Posted | Number | percent of positive responses | 16 weeks |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 10 |
| 60 |
| Pain | General disorders | Non-systematic Assessment |
|
| Numbness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Anxiety | General disorders | Non-systematic Assessment |
|
| Vasovagal event | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
|
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| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| Title | Measurements |
|---|---|
|
| Overall effect was about, or more than expected |
|
| Overall satisfaction with the procedure |
|
| Would repeat the procedure |
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| Would have the procedure on different body part |
|
| Would recommend the procedure |
|