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Evaluate the safety and efficacy of abdominal DualSculpting with CoolAdvantage applicators.
The study will evaluate the safety and efficacy of non-invasive fat reduction in the abdomen using two applicators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zeltiq Dual Sculpting Treatment Group | Experimental | All subjects treated with CoolSculpting System using the CoolAdvantage and CoolAdvantage Plus applicators simultaneously on the abdomen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The ZELTIQ System | Device | The CoolSculpting System will be used to perform the treatments with the CoolAdvantage family of applicators. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Correctly Identified Photos by Blinded Reviewers | 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 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 primary efficacy endpoint of the study was the correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment images by two out of three blinded, independent reviewers. Success was defined as at least 70% correct identification of the baseline (pre-treatment) photographs. | Baseline to 12 weeks post-treatment |
| Safety of the Zeltiq Device | The incidence of unanticipated adverse device effects will be measured. It is expected there will be zero UADEs. | 12 week post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction | Subject satisfaction with the Zeltiq procedure as determined by positive responses in a subject satisfaction questionnaire administered at the 12 weeks post-treatment visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses, with lower numbers (e.g. 1 or 2) indicating positive responses and higher numbers indicating less positive responses. |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Main Line Center for Laser Surgery | Ardmore | Pennsylvania | 19003 | United States |
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Protocol defined inclusion and exclusion conditions determined study entry. All subjects were included in the single arm study.
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| ID | Title | Description |
|---|---|---|
| FG000 | CoolSculpting of the Abdomen | Non-invasive fat reduction of the abdomen will be performed using the Zeltiq CoolSculpting System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Candidates who sought reduction of fat in the abdomen and who the investigator has assessed to be eligible for multiple DualSculpting treatments in the abdomen were eligible to participate.
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| ID | Title | Description |
|---|---|---|
| BG000 | CoolSculpting of the Abdomen With Dual Applicators | Non-invasive fat reduction of the abdomen was performed using the Zeltiq CoolSculpting System using dual applicators. |
| Units | Counts |
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| 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 Photos by Blinded Reviewers | 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 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 primary efficacy endpoint of the study was the correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment images by two out of three blinded, independent reviewers. Success was defined as at least 70% correct identification of the baseline (pre-treatment) photographs. | Fourteen of 15 treated subjects were included in the per-protocol analysis. One subject was excluded from analysis due to a protocol-defined weight maintenance requirement. Pre-treatment and post-treatment photos were evaluated by 3 independent physician reviewers. | Posted | Count of Units | photos | Baseline to 12 weeks post-treatment | photos | photos |
Adverse event data was solicited continuously throughout the study. The final follow-up visit occurred 12 weeks post-treatment.
Adverse events (AE) will be assessed continuously throughout the study. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device. Common minor health complaints related to the upper respiratory tract (e.g. rhinitis, influenza, common cold) will not be documented as adverse events.
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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 of the Abdomen With Dual Applicators | Non-invasive fat reduction of the abdomen was performed using the Zeltiq CoolSculpting System using dual applicators. |
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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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| 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 | Oct 6, 2016 | Jun 5, 2020 | Prot_SAP_000.pdf |
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| 12 weeks post-treatment |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index | Mean | Full Range | kg/m^2 |
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| Primary | Safety of the Zeltiq Device | The incidence of unanticipated adverse device effects will be measured. It is expected there will be zero UADEs. | The "as-treated" population included all subjects who were treated with CoolSculpting. | Posted | Number | device-or procedure-related AEs | 12 week post-treatment |
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| Secondary | Subject Satisfaction | Subject satisfaction with the Zeltiq procedure as determined by positive responses in a subject satisfaction questionnaire administered at the 12 weeks post-treatment visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses, with lower numbers (e.g. 1 or 2) indicating positive responses and higher numbers indicating less positive responses. | The per-protocol population consisted of 14 subjects. One subject was excluded for weight gain >5%, a protocol defined limit for weight maintenance and was excluded from the analysis. | Posted | Count of Participants | Participants | 12 weeks post-treatment |
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| Title | Measurements |
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| Would recommend to a friend |
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