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The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction with an alternative treatment parameter.
The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in the flank.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoolSculpting of the Flank With Alternate Treatment Parameters | Experimental | Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Zeltiq CoolSculpting System | Device | Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Device and/or Procedure-Related Adverse Events | The number of device- or procedure-related adverse events will be tabulated. Adverse event reports are collected throughout the study from enrollment through the 16 week follow-up visit. The investigator determines if there is a relationship between the event and the study device or procedure. | Enrollment through 16 weeks post-treatment visit, which is approximately 5 months |
| 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 untreated contralateral flank 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. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated flank as compared to the untreated control flank. Results indicate the fat layer reduction in millimeters. | Pre-treatment and 16 weeks post-treatment |
| 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. Images show both treated and untreated flanks. Reviewers will be practicing dermatologists or plastic surgeons. 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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatments; subject has complete set of baseline photos and post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80% correct identification. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Kilmer, MD | Laser and Skin Surgery Center of Northern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser & Skin Surgery Center of Northern California | Sacramento | California | 95816 | United States | ||
| Dallas Plastic Surgery Institute |
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Patients who seek reduction of fat in the flanks will be recruited from the general population.
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| ID | Title | Description |
|---|---|---|
| FG000 | CoolSculpting Intervention | CoolSculpting treatments were performed on one (1) flank in a single treatment visit. The contralateral flank served as the untreated control. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | CoolSculpting Intervention | CoolSculpting treatments were performed on one (1) flank in a single treatment visit. |
| 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 | The Number of Device and/or Procedure-Related Adverse Events | The number of device- or procedure-related adverse events will be tabulated. Adverse event reports are collected throughout the study from enrollment through the 16 week follow-up visit. The investigator determines if there is a relationship between the event and the study device or procedure. | The safety population includes all subjects treated with CoolSculpting. | Posted | Number | device or procedure-related AEs | Enrollment through 16 weeks post-treatment visit, which is approximately 5 months |
|
Adverse events were collected from enrollment through 131 days post-treatment.
Protocol defined AE definitions: Adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device. Adverse event data were aggregated for the study population as all subjects were treated with the Zeltiq System, with each subject having a treated flank and an untreated flank.
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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 Flank -Subjects With Systemic AEs | Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged numbness in treatment area | Skin and subcutaneous tissue 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 post-treatment |
| 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. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses. | 16 weeks post-treatment |
| Dallas |
| Texas |
| 75231 |
| United States |
| Arbutus Laser Centre | Vancouver | British Columbia | V6JIZ6 | Canada |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Full Range | kg/m^2 |
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| Primary | 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 untreated contralateral flank 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. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated flank as compared to the untreated control flank. Results indicate the fat layer reduction in millimeters. | Thirty-five subjects were included in the per-protocol analysis population: 1 subject was LTFU, 2 subjects did not complete the 16 week follow-up visit when ultrasonographer was present and 1 subject received an incomplete treatment. Six additional subjects had weight change greater than the protocol defined 5 pounds at the final follow-up visit. | Posted | Mean | Standard Deviation | mm | Pre-treatment and 16 weeks post-treatment |
|
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|
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| Secondary | 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. Images show both treated and untreated flanks. Reviewers will be practicing dermatologists or plastic surgeons. 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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatments; subject has complete set of baseline photos and post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80% correct identification. | The study population consisted of 45 participants. 1 subject was lost to follow-up; 1 subject had an incomplete treatment and photos of 1 subject were poor quality. Of the remaining 42 subjects, 7 did not maintain weight per protocol. 35 sets of subject photos were included in the analysis. Each image showed both treated and untreated flanks; both "arms" were included in the photo review. | Posted | Count of Units | photos | 16 weeks post-treatment | photos | photos |
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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. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses. | Of the 45 study participants, one subject received incomplete treatment and did not complete the questionnaire and one subject was lost to follow-up. Free text responses and inconclusive responses were excluded from analysis. | Posted | Count of Participants | Participants | 16 weeks post-treatment |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 7 |
| 45 |
| EG001 | Flank Treated With CoolSculpting Group | One flank on each enrolled subject was treated with CoolSculpting. | 0 | 45 | 0 | 45 | 12 | 45 |
| EG002 | UnTreated Contralateral Flank | Each enrolled subject had one flank that was untreated, and no intervention was used. | 0 | 45 | 0 | 45 | 0 | 45 |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| First degree burn | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Subcutaneous induration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Post-treatment pain | General disorders | Non-systematic Assessment |
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| Cough and/or cold | General disorders | Non-systematic Assessment |
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| Bronchitis and strep throat | Infections and infestations | Non-systematic Assessment |
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| Sinus infection | Infections and infestations | Non-systematic Assessment |
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| Influenza | Infections and infestations | Non-systematic Assessment |
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| Anxiety | General disorders | Non-systematic Assessment |
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| Fractured heel | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Allergic reaction | General disorders | Non-systematic Assessment |
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| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| Title | Measurements |
|---|---|
|
| Somewhat to very different fit of clothing |
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| Somewhat to very satisfied with procedure/results |
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| Somewhat likely to likely to have another procedur |
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| Very to somewhat likely to have same area treated |
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| Would recommend procedure to a friend |
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