Trial Outcomes & Findings for Multiple CoolSculpting Treatment Study (NCT NCT01814007)
NCT ID: NCT01814007
Last Updated: 2021-05-17
Results Overview
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.
COMPLETED
NA
35 participants
Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment
2021-05-17
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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35
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Overall Study
COMPLETED
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34
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
Multiple CoolSculpting Treatment Study
Baseline characteristics by cohort
| Measure |
Treatment Group
n=35 Participants
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.
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|---|---|
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Age, Continuous
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45.2 years
STANDARD_DEVIATION 2.2 • n=5 Participants
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Sex: Female, Male
Female
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27 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
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Region of Enrollment
United States
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35 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
CoolSculpting Treatment Group
n=35 Participants
CoolSculpting of Abdomen and Flanks
The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
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|---|---|
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Evaluation of Liver- Related Tests Over Time
Baseline Alk Phosphatase
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62.12 units per liter (U/L)
Standard Deviation 15.72
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Evaluation of Liver- Related Tests Over Time
1 week post treatment Alk Phosphatase
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63.88 units per liter (U/L)
Standard Deviation 14.71
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Evaluation of Liver- Related Tests Over Time
4 weeks post treatment Alk Phosphatase
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63.74 units per liter (U/L)
Standard Deviation 15.61
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Evaluation of Liver- Related Tests Over Time
ALT-SGPT 1 week post treatment
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20.44 units per liter (U/L)
Standard Deviation 12.4
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Evaluation of Liver- Related Tests Over Time
ALT-SGPT 4 weeks post treatment
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20 units per liter (U/L)
Standard Deviation 10.57
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Evaluation of Liver- Related Tests Over Time
12 week post treatment Alk Phosphatase
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62.06 units per liter (U/L)
Standard Deviation 15.4
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Evaluation of Liver- Related Tests Over Time
Baseline AST-SGOT
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19.66 units per liter (U/L)
Standard Deviation 5.16
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Evaluation of Liver- Related Tests Over Time
1 week post treatment AST-SGOT
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19.76 units per liter (U/L)
Standard Deviation 6.93
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Evaluation of Liver- Related Tests Over Time
4 weeks post treatment AST-SGOT
|
22.15 units per liter (U/L)
Standard Deviation 8.77
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Evaluation of Liver- Related Tests Over Time
12 week post treatment AST-SGOT
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23.03 units per liter (U/L)
Standard Deviation 16.33
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Evaluation of Liver- Related Tests Over Time
ALT-SGPT Baseline
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17.68 units per liter (U/L)
Standard Deviation 7.48
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Evaluation of Liver- Related Tests Over Time
ALT-SGPT 12 weeks post treatment
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19.35 units per liter (U/L)
Standard Deviation 15.27
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PRIMARY outcome
Timeframe: Pretreatment, 1 week, 4 weeks 12 weeks post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
CoolSculpting Treatment Group
n=35 Participants
CoolSculpting of Abdomen and Flanks
The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
|---|---|
|
Evaluation of Liver-Related Tests Over Time
Total Bilirubin Baseline
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0.65 mg/dl
Standard Deviation 0.36
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Evaluation of Liver-Related Tests Over Time
Total Bilirubin 1 week
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0.53 mg/dl
Standard Deviation 0.24
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Evaluation of Liver-Related Tests Over Time
Total Bilirubin 4 weeks
|
0.61 mg/dl
Standard Deviation 0.27
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Evaluation of Liver-Related Tests Over Time
Total Bilirubin 12 weeks
|
0.58 mg/dl
Standard Deviation 0.28
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PRIMARY outcome
Timeframe: Pre-treatment, 1 week, 4 weeks, 12 weeks post-treatmentPopulation: Of the 35 subjects enrolled, 1 subject withdrew and did not have blood draws performed after the baseline visit.
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.
Outcome measures
| Measure |
CoolSculpting Treatment Group
n=35 Participants
CoolSculpting of Abdomen and Flanks
The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
|---|---|
|
Evaluation of Serum Lipid Values Over Time
Cholesterol Baseline
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186.54 mg/dl
Standard Deviation 39.08
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Evaluation of Serum Lipid Values Over Time
Cholesterol 1 week
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185.62 mg/dl
Standard Deviation 36.9
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Evaluation of Serum Lipid Values Over Time
Cholesterol 4 weeks
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188.38 mg/dl
Standard Deviation 37.6
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Evaluation of Serum Lipid Values Over Time
Cholesterol 12 weeks
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189.18 mg/dl
Standard Deviation 39.76
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Evaluation of Serum Lipid Values Over Time
Triglycerides Baseline
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76.97 mg/dl
Standard Deviation 32.49
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Evaluation of Serum Lipid Values Over Time
Triglycerides 1 week
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80.53 mg/dl
Standard Deviation 33.19
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Evaluation of Serum Lipid Values Over Time
Triglycerides 4 weeks
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77.68 mg/dl
Standard Deviation 33.22
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Evaluation of Serum Lipid Values Over Time
Triglycerides 12 weeks
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83.35 mg/dl
Standard Deviation 38.59
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Evaluation of Serum Lipid Values Over Time
HDL Cholesterol Baseline
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71.03 mg/dl
Standard Deviation 26.83
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Evaluation of Serum Lipid Values Over Time
HDL Cholesterol 1 week
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68.56 mg/dl
Standard Deviation 26.35
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Evaluation of Serum Lipid Values Over Time
HDL Cholesterol 4 weeks
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70.59 mg/dl
Standard Deviation 27.36
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Evaluation of Serum Lipid Values Over Time
HDL Cholesterol 12 weeks
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73.79 mg/dl
Standard Deviation 31.69
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Evaluation of Serum Lipid Values Over Time
LDL Cholesterol Baseline
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99.97 mg/dl
Standard Deviation 23.12
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Evaluation of Serum Lipid Values Over Time
LDL Cholesterol 1 week
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100.94 mg/dl
Standard Deviation 26.78
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Evaluation of Serum Lipid Values Over Time
LDL Cholesterol 4 weeks post treatment
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102.65 mg/dl
Standard Deviation 21.73
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Evaluation of Serum Lipid Values Over Time
LDL Cholesterol 12 weeks post treatment
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102.5 mg/dl
Standard Deviation 28.72
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Evaluation of Serum Lipid Values Over Time
VLDL Cholesterol Baseline
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15.67 mg/dl
Standard Deviation 6.83
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Evaluation of Serum Lipid Values Over Time
VLDL Cholesterol 1 week
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16.12 mg/dl
Standard Deviation 6.5
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Evaluation of Serum Lipid Values Over Time
VLDL Cholesterol 4 weeks post treatment
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15.45 mg/dl
Standard Deviation 6.62
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Evaluation of Serum Lipid Values Over Time
VLDL Cholesterol 12 weeks post treatment
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16.8 mg/dl
Standard Deviation 7.85
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PRIMARY outcome
Timeframe: 12 weeks post treatmentPopulation: All treated subjects were included in the safety analysis population.
The primary safety end point is the incidence of Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).
Outcome measures
| Measure |
CoolSculpting Treatment Group
n=35 Participants
CoolSculpting of Abdomen and Flanks
The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
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|---|---|
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Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE
Serious AE reported
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1 participants
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Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE
UADEs reported
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0 participants
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SECONDARY outcome
Timeframe: 12 weeks post-treatmentPopulation: All subjects treated with the CoolSculpting device were included in the analysis population.
All adverse will be assessed for frequency and severity from the time of enrollment though the 12 week follow-up visit.
Outcome measures
| Measure |
CoolSculpting Treatment Group
n=35 Participants
CoolSculpting of Abdomen and Flanks
The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
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|---|---|
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Safety as Evaluated by the Number and Severity of All Reported Adverse Events.
Moderate severity AE
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1 Participants
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Safety as Evaluated by the Number and Severity of All Reported Adverse Events.
Mild severity AE
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2 Participants
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SECONDARY outcome
Timeframe: Treatment day and 12 week post-treatment follow-upPopulation: 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.
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.
Outcome measures
| Measure |
CoolSculpting Treatment Group
n=35 Participants
CoolSculpting of Abdomen and Flanks
The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
|---|---|
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Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment.
Post Treatment Pain Score
|
4 score on a scale
Standard Deviation 3
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Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment.
12-week Pain Score
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0 score on a scale
Standard Deviation 0
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SECONDARY outcome
Timeframe: Treatment day and 12 week post-treatment follow-upPopulation: 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.
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.
Outcome measures
| Measure |
CoolSculpting Treatment Group
n=103 Treatment sites
CoolSculpting of Abdomen and Flanks
The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
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|---|---|
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Side Effects in Treatment Area
Bruising absent at 12 wks
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102 Treatment sites
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Side Effects in Treatment Area
Bruising absent immed post treatment
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64 Treatment sites
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Side Effects in Treatment Area
Minor bruising immed post treatment
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31 Treatment sites
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Side Effects in Treatment Area
Moderate bruising immed post treatment
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7 Treatment sites
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Side Effects in Treatment Area
Severe bruising immed post treatment
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1 Treatment sites
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Side Effects in Treatment Area
Erythema absent immed post treatment
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0 Treatment sites
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Side Effects in Treatment Area
Minor erythema immed post treatment
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54 Treatment sites
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Side Effects in Treatment Area
Moderate erythema immed post treatment
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46 Treatment sites
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Side Effects in Treatment Area
Severe erythema immed post treatment
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3 Treatment sites
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Side Effects in Treatment Area
Edema absent immed post treatment
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31 Treatment sites
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Side Effects in Treatment Area
Minor edema immed post treatment
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46 Treatment sites
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Side Effects in Treatment Area
Moderate edema immed post treatment
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25 Treatment sites
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Side Effects in Treatment Area
Severe edema immed post treatment
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1 Treatment sites
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Side Effects in Treatment Area
Numbness absent immed post treatment
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14 Treatment sites
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Side Effects in Treatment Area
Minor numbness immed post treatment
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30 Treatment sites
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Side Effects in Treatment Area
Moderate numbness immed post treatment
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47 Treatment sites
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Side Effects in Treatment Area
Severe numbness immed post treatment
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12 Treatment sites
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Side Effects in Treatment Area
Tingling absent immed post treatment
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56 Treatment sites
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Side Effects in Treatment Area
Minor tingling immed post treatment
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32 Treatment sites
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Side Effects in Treatment Area
Moderate tingling immed post treatment
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12 Treatment sites
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Side Effects in Treatment Area
Severe tingling immed post treatment
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3 Treatment sites
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Side Effects in Treatment Area
Other skin effect immed post treatment
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1 Treatment sites
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Side Effects in Treatment Area
Erythema absent at 12 weeks
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102 Treatment sites
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Side Effects in Treatment Area
Edema absent at 12 weeks
|
102 Treatment sites
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Side Effects in Treatment Area
Numbness absent at 12 weeks
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102 Treatment sites
|
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Side Effects in Treatment Area
Tingling absent at 12 weeks
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102 Treatment sites
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Side Effects in Treatment Area
Other skin effect absent at 12 weeks at 12 weeks
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102 Treatment sites
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Adverse Events
CoolSculpting Treatment Group
Serious adverse events
| Measure |
CoolSculpting Treatment Group
n=35 participants at risk
All subjects treated with the CoolSculpting System are included in the CoolSculpting Treatment Group.
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|---|---|
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Gastrointestinal disorders
Inguinal hernia repair
|
2.9%
1/35 • Number of events 1 • 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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Other adverse events
| Measure |
CoolSculpting Treatment Group
n=35 participants at risk
All subjects treated with the CoolSculpting System are included in the CoolSculpting Treatment Group.
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|---|---|
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Hepatobiliary disorders
Liver related test results out of normal range
|
2.9%
1/35 • Number of events 1 • 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.
|
|
Infections and infestations
Bronchitis
|
2.9%
1/35 • Number of events 1 • 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.
|
Additional Information
Kerrie Jiang, Executive Director Regulatory, Clinical and Medical Affairs
Zeltiq Aesthetics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place