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The purpose of this study is to compare the performance of the Zeltiq CoolSculpting System using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.
The purpose of this study is to compare the performance of a cryolipolysis system using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lateral Thigh Treatment Group | Experimental | All subjects were treated on both thighs with the CoolSculpting System. One lateral thigh was treated using a protocol-defined temperature for 120 minutes. The contralateral thigh was treated at a protocol defined temperature for 60 minutes for 18 subjects. Twenty-two subjects were treated on the contralateral outer thigh with a 3rd protocol-defined temperature for 60 minutes. |
|
| 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 |
|---|---|---|
| Safety of the Zeltiq Device | The number of device- or procedure-related adverse events will be tabulated from the time of enrollment through the 16 week follow-up visit. | Time of enrollment though16 weeks post-treatment (approximately 5 months) |
| Safety of the Zeltiq Device | The number of unanticipated adverse device effects (UADEs) will be tabulated. | From enrollment through 16 week follow-up (approximately 5 months) |
| Percentage 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 of the treated areas. 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. 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 80%. | Baseline and 16 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 adjacent untreated 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 (untreated area) 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 region as compared to the untreated control. Results indicate the mean fat layer reduction in mm. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Eric Bachelor, MD | Innovation Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marina Plastic Surgery | Marina del Rey | California | 90292 | United States | ||
| Innovation Research Center |
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A total of 40 enrolled subjects, initiated treatment and had safety evaluations after treatment (safety population). The Per-Protocol Population included all treated subjects who completed treatment, were followed for 16 weeks and who did not become pregnant and with weight change of no more than 5 pounds at the time the final post-treatment images were taken.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lateral Thigh Treatment Group | Each subject was treated on one lateral thigh at -10 degrees C. The contralateral thigh was treated at -13 degrees C for 60 minutes for 18 subjects. The contralateral thigh on 21 subjects was treated at -15 degrees for 60 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lateral Thigh Treatment Group | Non-invasive fat reduction of both lateral thighs was performed using the Zeltiq CoolSculpting System. |
| 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 | Safety of the Zeltiq Device | The number of device- or procedure-related adverse events will be tabulated from the time of enrollment through the 16 week follow-up visit. | All subjects treated with the Zeltiq CoolSculpting System were included in the analysis population. | Posted | Number | device/procedure related AEs | Time of enrollment though16 weeks post-treatment (approximately 5 months) |
|
Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months.
The Safety Population consists of all enrolled participants who received a treatment session (started or completed).
AEs of Nausea, Seasonal Allergies, Sinus Cold, Lumbar Cyst, Surgical Procedure, Menstrual Irregularity, Uterine Fibroid, and Pneumonia are presented in multiple arms because they were not attributable to a given intervention.
One incident of Prolonged Sensory Alteration Post Procedure that occurred outside of the treatment area was reported for -10 C and -15 C arms.
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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 | Lateral Thigh Treatment Parameter: -10C | All subjects received treatment on one (1) lateral thigh at -10C. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperpigmentation | 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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All subjects to be treated on one lateral thigh at a protocol-defined temperature for 120 minutes. Treatment of the contralateral thigh was performed using two unique protocol-defined temperatures for 60 minutes.
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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. The questionnaire is composed of a 5-point Likert scale questions, as well as free text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied or satisfied; 4) somewhat satisfied; 5) very satisfied. | 16-weeks post treatment |
| Pleasanton |
| California |
| 94588 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Full Range | kg//m^2 |
|
| OG002 | Contralateral Thigh Treatment Parameter:-15C | Contralateral lateral thigh was treated using -15C. |
|
|
| Primary | Safety of the Zeltiq Device | The number of unanticipated adverse device effects (UADEs) will be tabulated. | All subjects treated with the Zeltiq CoolSculpting System were included in the analysis population. | Posted | Number | UADEs reported | From enrollment through 16 week follow-up (approximately 5 months) |
|
|
|
| Primary | Percentage 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 of the treated areas. 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. 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 80%. | The per-protocol analysis population included subjects with available photos and complied with protocol-defined weight maintenance. Thirty-four subjects had 68 photo pairs which were presented to three blinded physician reviewers.Of the 37 subjects with available photos, 3 subjects were excluded due to weight change outside of protocol requirements. | Posted | Count of Units | photos | Baseline and 16 weeks post-treatment | photos | photos |
|
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|
|
| Secondary | 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 adjacent untreated 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 (untreated area) 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 region as compared to the untreated control. Results indicate the mean fat layer reduction in mm. | The per-protocol analysis population included 33 subjects with available ultrasound images for both lateral thighs, resulting in 66 images for analysis. | Posted | Mean | Standard Deviation | mm | 16 weeks post-treatment |
|
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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. The questionnaire is composed of a 5-point Likert scale questions, as well as free text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied or satisfied; 4) somewhat satisfied; 5) very satisfied. | Subjects completing the questionnaire at the 16-week follow-up visit were included in the analysis population. | Posted | Count of Participants | Participants | 16-weeks post treatment |
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|
| 0 |
| 40 |
| 0 |
| 40 |
| 17 |
| 40 |
| EG001 | Contralateral Thigh Treatment Parameter: -13C | Subjects with contralateral lateral thigh treatment at -13C. | 0 | 18 | 0 | 18 | 6 | 18 |
| EG002 | Contralateral Thigh Treatment Parameter:-15C | Contralateral lateral thigh was treated using -15C. | 0 | 22 | 0 | 22 | 20 | 22 |
| Prolonged sensory alteration post procedure | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sinus cold | General disorders | Non-systematic Assessment |
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| Uterine fibroid | Reproductive system and breast disorders | Non-systematic Assessment |
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| Menstrual irregularity | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Surgical procedure | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lumbar cyst | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Seasonal allergies | General disorders | Non-systematic Assessment |
|
| Dry, flaky skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| photos |
|
| 77.4 |
| 2-Sided |
| 95 |
| 68.1 |
| 85.1 |
| Other |
| sucess percentage | 79.2 | 2-Sided | 95 | 65.0 | 89.5 | Other |
| sucess percentage | 94 | 2-Sided | 95 | 84.6 | 98.8 | Other |
| Mean Difference (Net) |
| 1.3 |
| 2-Sided |
| 95 |
| 0.5 |
| 2.1 |
| Other |
| Mean Difference (Net) | 3.0 | 2-Sided | 95 | 2.0 | 4.1 | Other |
| Title | Measurements |
|---|---|
|
| More than or about expected overall effect |
|
| Very to somewhat satisfied with procedure |
|