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The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zeltiq Dermal Cooling Device | Device | Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Visible Improvement in Treated Area | Investigator assessment to document any visible improvement in the treatment area. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction | Percentage satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Sacramento | California | United States | |||
| Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Non-invasive cooling was applied to the treatment area with a defined cooling rate and duration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Zeltiq Dermal Cooling Device: Non-invasive cooling was applied to the treatment area with a defined cooling rate and duration. |
| 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 | Percentage of Participants With Visible Improvement in Treated Area | Investigator assessment to document any visible improvement in the treatment area. | Participants with evaluable data for each body site were included in this analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 4 months |
|
All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
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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 | All Participants | Non-invasive cooling was applied to the treatment area with a defined cooling rate and duration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sally Hallas, RN | AbbVie | 209-294-5571 | sally.hallas@abbvie.com |
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| San Diego |
| California |
| United States |
| Investigational Site | Washington D.C. | District of Columbia | United States |
| Investigational Site | Miami | Florida | United States |
| Investigational Site | Chicago | Illinois | United States |
| Investigational Site | Baltimore | Maryland | United States |
| Investigational Site | Boston | Massachusetts | United States |
| Investigational Site | Minneapolis | Minnesota | United States |
| Investigational Site | Hackensack | New Jersey | United States |
| Investigational Site | New York | New York | United States |
| Investigational Site | Dallas | Texas | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Participant Satisfaction | Percentage satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire. | Participants with evaluable data for each body site were included in this analysis. The row titled "Percentage of participants 'Both Satisfied and Dissatisfied' on Subject Satisfaction Questionnaire" was not applicable to the Love Handle treatment area, so no data were collected. | Posted | Number | 95% Confidence Interval | percentage of participants | 4 months |
|
|
|
| 0 |
| 175 |
| 0 |
| 175 |
| 12 |
| 175 |
| Fainting | Vascular disorders | Non-systematic Assessment |
|
| Chest Pain | General disorders | Non-systematic Assessment |
|
| Elevated Heart Rate | Cardiac disorders | Non-systematic Assessment |
|
| Hyperlipidemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Vasovagal event | General disorders | Non-systematic Assessment |
|
| Gallbladder attack | Hepatobiliary disorders | Non-systematic Assessment |
|
| Toe Pain | General disorders | Non-systematic Assessment |
|
| Tingling | Nervous system disorders | Non-systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Rib Soreness | General disorders | Non-systematic Assessment |
|
| General disorders | Non-systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Percentage of participants "Dissatisfied" on Subject Satisfaction Questionnaire |
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| Percentage of participants "Neither Satisfied nor Dissatisfied"on Subject Satisfaction Questionnaire |
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| Percentage of participants "Both Satisfied and Dissatisfied" on Subject Satisfaction Questionnaire |
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