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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.
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 using the Zeltiq Dermal Cooling device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental | Cooling Intensity Factor = 33 Duration = 60 minutes |
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| Treatment Group 2 | Experimental | Cooling Intensity Factor = 37 Duration = 30 minutes |
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| Treatment Group 3 | Experimental | Cooling Intensity Factor = 37 Duration = 45 minutes |
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| Treatment Group 4 | Experimental | Cooling Intensity Factor = 42 Cooling Duration = 30 minutes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zeltiq Dermal Cooling Device | Device | Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Fat Layer Thickness of the Treated Flank | The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group. | Baseline and 6 months |
| Percentage of Subjects Expressing Satisfaction With the Procedure | Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits. | 6 months post-treatment follow-up visit |
| Percentage of Correctly Identified Pre-treatment Photographs | Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. 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.Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. Results reflect the percentage of correctly identified images. | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerrie Jiang | Zeltiq Aesthetics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Dublin | California | United States | |||
| Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group 1 | Cooling Intensity Factor = 33 Duration = 60 minutes Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration. |
| FG001 | Treatment Group 2 | Cooling Intensity Factor = 37 Duration = 30 minutes Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration. |
| FG002 | Treatment Group 3 | Cooling Intensity Factor = 37 Duration = 45 minutes Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration. |
| FG003 | Treatment Group 4 | Cooling Intensity Factor = 42 Cooling Duration = 30 minutes Zeltiq Dermal Cooling Device: Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Treated with CIF 33 for 60 minutes.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group 1 | Subjects in Treatment Group 1 were treated using a Cooling Intensity Factor (CIF) of 33 for 60 minutes. |
| BG001 | Treatment Group 2 | Subjects in Treatment Group 2 were treated using CIF 37 for 30 minutes. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change in Fat Layer Thickness of the Treated Flank | The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group. | The population includes only subjects with evaluable ultrasound data ( >3 valid images at 6 month follow up visit). Group 1 exclusions: 2 Lost To Follow Up and 6 not evaluable; Group 2 exclusions: 1 not evaluable; Group 3 exclusions: 3 not evaluable; Group 4 exclusions: 1 not evaluable and 1 withdrawn from study by Investigator. | Posted | Mean | Standard Error | percent fat layer change | Baseline and 6 months |
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Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 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 | Treatment Group 1 | Subjects from Group 1 were treated using a CIF of 33 for 60 minutes in duration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kerrie Jiang, Director of Regulatory, Clinical and Medical Affairs | Zeltiq Aesthetics | (925) 621-7462 | kerrie.jiang@allergan.com |
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| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Fremont |
| California |
| United States |
| Investigational Site | Pleasanton | California | United States |
| Investigational Site | San Ramon | California | United States |
| BG002 | Treatment Group 3 | Subjects in Treatment Group 3 were treated using CIF 37 for 45 minutes. |
| BG003 | Treatment Group 4 | Subjects in Treatment Group 4 were treated using CIF 42 for 30 minutes. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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All subjects treated in Groups 1, 2, 3 and 4 are combined for this analysis. |
| OG001 | Group 1 | CIF 33 for 60 minutes |
| OG002 | Group 2 | CIF 37 30 minute duration |
| OG003 | Group 3 | CIF 37 duration 45 minutes |
| OG004 | Group 4 | CIF 42 30 duration 30 minutes |
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| Primary | Percentage of Subjects Expressing Satisfaction With the Procedure | Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits. | 56 subjects completed the questionnaire; 2 subjects were LTFU, 1 subject failed to complete the questionnaire and 1 subject was withdrawn from the study by the Investigator. Four (4) subjects did not respond to one question on the questionnaire; 1 subject did not respond to another question on the questionnaire. | Posted | Mean | Standard Deviation | percent positive responses | 6 months post-treatment follow-up visit |
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| Primary | Percentage of Correctly Identified Pre-treatment Photographs | Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. 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.Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. Results reflect the percentage of correctly identified images. | The analysis population included subjects who had evaluable photos from baseline and the 6 month final follow-up visit. Subjects who did not maintain their weight per protocol requirements were excluded from analysis. | Posted | Mean | Standard Error | percent correctly identified images | Baseline and 6 months |
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| 0 |
| 28 |
| 0 |
| 28 |
| 1 |
| 28 |
| EG001 | Treatment Group 2 | Subjects from Group 2 were treated using a CIF of 37 for 30 minutes in duration. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG002 | Treatment Group 3 | Subjects in Treatment Group 3 were treated using a CIF of 37 for 45 minutes in duration. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG003 | Treatment Group 4 | Subjects in Treatment Group 4 were treated using a CIF of 42 for 30 minutes in duration. | 0 | 10 | 0 | 10 | 1 | 10 |
| Bruising | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Muscle spasm | General disorders | Non-systematic Assessment |
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| Agree there is a change to the treated area |
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| Agree change to treated area was improvement |
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| Expectations were met or exceeded |
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| Discomfort was no greater than expected |
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