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To evaluate the safety of same-day CoolSculpting treatments and to assess the impact on serum lipids and liver-related tests.
The study will evaluate the safety of multiple same-day CoolSculpting treatments and will assess any impact on serum lips or liver-related analytes,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoolSculpting Treatment Group | Experimental | CoolSculpting treatments will be performed on all subjects with 1 cooling cycle on the lower abdomen, plus simultaneous treatment of both flanks, one cooling cycle each. Two control units will be utilized at protocol-defined temperatures and durations. |
|
| 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 |
|---|---|---|
| Evaluation of Liver- Related Tests Over Time | Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory value over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness. | Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment |
| Evaluation of Liver-Related Tests Over Time | Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness. | Pretreatment, 1 week, 4 weeks 12 weeks post-treatment |
| Evaluation of Serum Lipid Values Over Time | Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as Evaluated by the Number and Severity of All Reported Adverse Events. | All adverse will be assessed for frequency and severity from the time of enrollment though the 12 week follow-up visit. | 12 weeks post-treatment |
| Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment. |
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Inclusion Criteria
Male or female subjects > 18 years of age.
Subject who has been assessed to receive multiple CoolSculpting treatments on the abdomen and flanks, defined as follows:
Subject has not had weight change exceeding 10 pounds in the preceding month.
Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
Subject agrees to not making any major changes in their diet or lifestyle during the course of the study.
Subject has read and signed a written informed consent form.
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Eric Bachelor, MD | Innovation Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovation Research Center | Pleasanton | California | 94588 | United States | ||
| Ed Becker, MD |
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| Label | URL |
|---|---|
| Multiple same day cryolipolysis treatments for the reduction of subcutaneous fat are safe and do not affect serum lipid levels or liver function tests | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | All study subjects are treated on the abdomen and flanks with the Zeltiq System: Non-invasive 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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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | All study subjects are treated on the abdomen with the Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Evaluation of Liver- Related Tests Over Time | Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory value over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness. | Blood draws completed on 35 subjects at baseline. Two liver-related test results unavailable for 1 subject at baseline. Blood draws at the 1 week, 4 week and 12 week time periods reflect 34 subjects as one of the 35 subjects enrolled withdrew from the study. Liver-related test values were analyzed for each time point. | Posted | Least Squares Mean | Standard Deviation | units per liter (U/L) | Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment |
Adverse event data was collected from the time of enrollment through the 12-week follow-up visit.
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. UADE = Any serious adverse effect on health and safety or any life-threatening problem or death caused by, or associated with a device.
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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 Treatment Group | All subjects treated with the CoolSculpting System are included in the CoolSculpting Treatment Group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia repair | Gastrointestinal disorders | Non-systematic Assessment | The subject reported an inguinal hernia to the site. Surgery was performed to repair the injury; the subject was discharged on the surgery day. Investigator determined the hernia was not related to the CoolSculpting device or procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver related test results out of normal range | Hepatobiliary disorders | Non-systematic Assessment | Blood draw performed at12 week time point showed elevation in ALT-SGOT and ALT-SGPT. Moderate ETOH consumption the night prior to the test was reported. The blood draw was repeated 2 months following. ALT-SGOT and ALT-SGPT were within normal limits. |
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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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|
| Pre-treatment, 1 week, 4 weeks, 12 weeks post-treatment |
| Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE | The primary safety end point is the incidence of Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE). | 12 weeks post treatment |
Pain scores are collected using a 0 (no pain) to 10 (worst possible pain) scale. Scores will be collected immediately post-treatment and at the 12 week follow-up visit. |
| Treatment day and 12 week post-treatment follow-up |
| Side Effects in Treatment Area | Clinical assessments of the skin at the treatment sites to be performed immediately post-treatment, and at the 12 week follow-up visit. Subjects will be evaluated for skin changes at the treatment sites. The scale used by clinicians for the assessments is 0 = absent, 1= minor, 2= moderate, 3= severe. | Treatment day and 12 week post-treatment follow-up |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Bowes Dermatology Group | Miami | Florida | 33133 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Evaluation of Liver-Related Tests Over Time | Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness. | Total bilirubin test results were not available for 2 subjects for the baseline visit. Of the 35 subjects enrolled in the study, 1 subject withdrew from the study and had no further blood draws. | Posted | Least Squares Mean | Standard Deviation | mg/dl | Pretreatment, 1 week, 4 weeks 12 weeks post-treatment |
|
|
|
| Primary | Evaluation of Serum Lipid Values Over Time | Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness. | Of the 35 subjects enrolled, 1 subject withdrew and did not have blood draws performed after the baseline visit. | Posted | Least Squares Mean | Standard Deviation | mg/dl | Pre-treatment, 1 week, 4 weeks, 12 weeks post-treatment |
|
|
|
| Primary | Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE | The primary safety end point is the incidence of Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE). | All treated subjects were included in the safety analysis population. | Posted | Number | participants | 12 weeks post treatment |
|
|
|
| Secondary | Safety as Evaluated by the Number and Severity of All Reported Adverse Events. | All adverse will be assessed for frequency and severity from the time of enrollment though the 12 week follow-up visit. | All subjects treated with the CoolSculpting device were included in the analysis population. | Posted | Count of Participants | Participants | 12 weeks post-treatment |
|
|
|
| Secondary | Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment. | Pain scores are collected using a 0 (no pain) to 10 (worst possible pain) scale. Scores will be collected immediately post-treatment and at the 12 week follow-up visit. | All subjects treated with the CoolSculpting System were included in the analysis population. One (1) subject was withdrawn from the study by the investigator after treatment, therefore pain scores reflect 35 subjects analyzed. | Posted | Mean | Standard Deviation | score on a scale | Treatment day and 12 week post-treatment follow-up |
|
|
|
| Secondary | Side Effects in Treatment Area | Clinical assessments of the skin at the treatment sites to be performed immediately post-treatment, and at the 12 week follow-up visit. Subjects will be evaluated for skin changes at the treatment sites. The scale used by clinicians for the assessments is 0 = absent, 1= minor, 2= moderate, 3= severe. | The analysis population included all subjects treated with the CoolSculpting System. 1 subject did not complete the final follow-up visit. The abdomen, left and right flanks were clinically assessed immediately post treatment and at 12 weeks. At 12 weeks, 102 treatment sites were assessed. | Posted | Number | Treatment sites | Treatment day and 12 week post-treatment follow-up | Treatment sites | Treatment sites |
|
|
|
| 0 |
| 35 |
| 1 |
| 35 |
| 2 |
| 35 |
|
|
| Bronchitis | Infections and infestations | Non-systematic Assessment | Subject reported fever and cough and was diagnosed with bronchitis. Antibiotics and nasal spray were prescribed. |
|
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| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
|
| Total Bilirubin 4 weeks |
|
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| Total Bilirubin 12 weeks |
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| Cholesterol 4 weeks |
|
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| Cholesterol 12 weeks |
|
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| Triglycerides Baseline |
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| Triglycerides 1 week |
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| Triglycerides 4 weeks |
|
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| Triglycerides 12 weeks |
|
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| HDL Cholesterol Baseline |
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| HDL Cholesterol 1 week |
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| HDL Cholesterol 4 weeks |
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| HDL Cholesterol 12 weeks |
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| LDL Cholesterol Baseline |
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| LDL Cholesterol 1 week |
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| LDL Cholesterol 4 weeks post treatment |
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| LDL Cholesterol 12 weeks post treatment |
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| VLDL Cholesterol Baseline |
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| VLDL Cholesterol 1 week |
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| VLDL Cholesterol 4 weeks post treatment |
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| VLDL Cholesterol 12 weeks post treatment |
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| Minor bruising immed post treatment |
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| Moderate bruising immed post treatment |
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| Severe bruising immed post treatment |
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| Erythema absent immed post treatment |
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| Minor erythema immed post treatment |
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| Moderate erythema immed post treatment |
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| Severe erythema immed post treatment |
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| Edema absent immed post treatment |
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| Minor edema immed post treatment |
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| Moderate edema immed post treatment |
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| Severe edema immed post treatment |
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| Numbness absent immed post treatment |
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| Minor numbness immed post treatment |
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| Moderate numbness immed post treatment |
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| Severe numbness immed post treatment |
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| Tingling absent immed post treatment |
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| Minor tingling immed post treatment |
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| Moderate tingling immed post treatment |
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| Severe tingling immed post treatment |
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| Other skin effect immed post treatment |
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| Bruising absent at 12 wks |
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| Erythema absent at 12 weeks |
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| Edema absent at 12 weeks |
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| Numbness absent at 12 weeks |
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| Tingling absent at 12 weeks |
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| Other skin effect absent at 12 weeks at 12 weeks |
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