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Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms.
Subcutaneous fat reduction of the upper arms using 2 vacuum applicator types will be done concurrently, such that a subject will have an applicator placed on each arm simultaneously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoolSculpting Treatment in the Upper Arm | Experimental | Subjects in the study were treated with the CoolSculpting System with one of two vacuum applicator types for bilateral fat reduction in the upper arms. Applicators were used concurrently, with an applicator on each arm. Each subject received 1 or 2 cooling cycles on each arm for 35 minutes at protocol-defined temperatures. The Investigator selected the applicator for each subject based on the intended fat volume of the treatment area. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The ZELTIQ CoolSculpting System | Device | The CoolSculpting device will be used to perform treatments. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Correctly Identified Pre-treatment Photos | 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. Reviewers are practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images are 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. The expected success rate is 70% correct identification by 2 out of 3 reviewers. | 12 weeks post-final treatment |
| Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms | The primary safety endpoint of the study is the incidence of unanticipated adverse device effects (UADE) reported in the study period. Investigators assessed each adverse event to determine if there was relationship to the study device or procedure. Adverse event data are collected from the time of study enrollment through the final follow-up visit at 12 weeks post-treatment. | Enrollment through12 weeks post-final treatment |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jason Rivers, MD | Pacific Dermaesthetics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Dermaesthetics | Vancouver | British Columbia | V6E 4M3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29566270 | Result | Rivers JK, Ulmer M, Vestvik B, Santos S. A customized approach for arm fat reduction using cryolipolysis. Lasers Surg Med. 2018 Mar 22. doi: 10.1002/lsm.22811. Online ahead of print. |
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Subjects seeking a reduction in upper arm fat were recruited from the general population.
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| ID | Title | Description |
|---|---|---|
| FG000 | CoolSculpting Intervention Group | The CoolSculpting System was used in the study. The study was designed to evaluate the safety and effectiveness of cryolypolysis for non-invasive reduction of upper arm fat. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Fifteen subjects were enrolled and treated in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | CoolSculpting Intervention Group | Subjects treated with CoolSculpting System for Arm Fat |
| 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 | Proportion of Correctly Identified Pre-treatment Photos | 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. Reviewers are practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images are 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. The expected success rate is 70% correct identification by 2 out of 3 reviewers. | The analysis population included subjects with baseline and post-treatment photos. | Posted | Count of Units | photos | 12 weeks post-final treatment | photos | photos |
Adverse event data was collected from enrollment through the 12-week post-treatment 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 | CoolSculpting Intervention Group | CoolSculpting Treatment for Arm Fat | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kerrie Jiang, Sr. Director, Regulatory, Clinical and Medical Affairs | Zeltiq Aesthetics | (925) 621-7462 | Kerrie.Jiang@allergan.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2016 | May 4, 2021 | Prot_SAP_000.pdf |
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| 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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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Full Range | kg/m^2 |
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| 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 scales 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. | Number | participants in skin type category |
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| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | CoolSculpting Intervention Group | Subjects treated with CoolSculpting for arm fat |
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| Primary | Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms | The primary safety endpoint of the study is the incidence of unanticipated adverse device effects (UADE) reported in the study period. Investigators assessed each adverse event to determine if there was relationship to the study device or procedure. Adverse event data are collected from the time of study enrollment through the final follow-up visit at 12 weeks post-treatment. | Each adverse event occurring in the per-protocol population of 15 subjects was evaluated by investigators for any relationship to the study device or procedure. | Posted | Number | number of participants with UADE | Enrollment through12 weeks post-final treatment |
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| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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