Trial Outcomes & Findings for Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature (NCT NCT01600638)
NCT ID: NCT01600638
Last Updated: 2020-10-26
Results Overview
Safety will be assessed by determination of the number of Unanticipated Adverse Device Effects (UADE) at the 8-week and 16-week post-treatment visits.
COMPLETED
NA
25 participants
8 weeks and 16 weeks post final treatment
2020-10-26
Participant Flow
Participant milestones
| Measure |
Zeltiq System Treatment Group
All subjects treated with the Zeltiq System are included in the treatment arm.
The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
|---|---|
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Overall Study
STARTED
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25
|
|
Overall Study
COMPLETED
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25
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature
Baseline characteristics by cohort
| Measure |
Zeltiq System Treatment Group
n=25 Participants
All subjects treated with the Zeltiq System are included in the treatment arm.
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, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
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37.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
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15 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Asian
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13 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Caucasian
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9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
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2 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Middle Eastern
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1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks and 16 weeks post final treatmentPopulation: All subjects treated with the Zeltiq System were included in the analysis population.
Safety will be assessed by determination of the number of Unanticipated Adverse Device Effects (UADE) at the 8-week and 16-week post-treatment visits.
Outcome measures
| Measure |
Zeltiq System Treatment Group
n=25 Participants
All subjects treated with the Zeltiq System are included in the treatment arm.
The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
|---|---|
|
Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature.
UADE reported at 8 weeks
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0 UADEs
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Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature.
UADE reported at 16 weeks
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0 UADEs
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PRIMARY outcome
Timeframe: 16 weeks post final treatmentPopulation: All subjects treated with the Zeltiq System were included in the analysis population.
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 contralateral 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 the untreated control from the change in treated area to remove the influence of weight variations. Results indicate the mm of fat layer reduction in the treated area.
Outcome measures
| Measure |
Zeltiq System Treatment Group
n=25 Participants
All subjects treated with the Zeltiq System are included in the treatment arm.
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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Change in Fat Layer Thickness When Compared to Untreated Control
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-1.3 mm
Standard Error 0.27
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SECONDARY outcome
Timeframe: 16 weeks post final treatmentPopulation: All eligible subjects treated with the Zeltiq System and who maintained weight within protocol requirements were included in the analysis population. Paired photos of each subject were reviewed by 3 independent reviewers to properly identify pre-treatment images.
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. Results reflect the proportion of correctly identified images.
Outcome measures
| Measure |
Zeltiq System Treatment Group
n=69 photos
All subjects treated with the Zeltiq System are included in the treatment arm.
The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
|---|---|
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Proportion of Pre-treatment Images Correctly Identified
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54 photos
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SECONDARY outcome
Timeframe: 16 weeks post final treatmentSubject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit.
Outcome measures
| Measure |
Zeltiq System Treatment Group
n=25 Participants
All subjects treated with the Zeltiq System are included in the treatment arm.
The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
|---|---|
|
Subject Satisfaction Questionnaire
Would recommend procedure to a friend
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100 percentage of participants
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Subject Satisfaction Questionnaire
Somewhat to very visible fat reduction
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40 percentage of participants
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Subject Satisfaction Questionnaire
Overall effect was more than or about was expected
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80 percentage of participants
|
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Subject Satisfaction Questionnaire
Overall satisfaction with procedure
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92 percentage of participants
|
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Subject Satisfaction Questionnaire
Would have additional areas treated
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16 percentage of participants
|
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Subject Satisfaction Questionnaire
Would have area re-treated again
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88 percentage of participants
|
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Subject Satisfaction Questionnaire
Would repeat procedure
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44 percentage of participants
|
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Subject Satisfaction Questionnaire
Procedure was somewhat to very comfortable
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80 percentage of participants
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Subject Satisfaction Questionnaire
Feel a difference in treated area
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36 percentage of participants
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SECONDARY outcome
Timeframe: Enrollment though 16 weeks post final treatmentPopulation: All subjects treated with the Zeltiq System were included in the analysis population.
The number of device or procedure-related adverse events will be evaluated. The investigator determines if the Zeltiq CoolSculpting System (device) or the treatment (procedure) are related to all reported adverse events.
Outcome measures
| Measure |
Zeltiq System Treatment Group
n=25 Participants
All subjects treated with the Zeltiq System are included in the treatment arm.
The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
|---|---|
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Additional Safety Evaluation
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3 Device/ procedure-related AE's
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Adverse Events
Zeltiq System Treatment Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zeltiq System Treatment Group
n=25 participants at risk
All subjects treated with the Zeltiq System are included in the treatment arm.
The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
|---|---|
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Skin and subcutaneous tissue disorders
Prolonged numbness
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8.0%
2/25 • Number of events 2 • Adverse event data was collected from the time of enrollment through the 16 week post-final follow-up visit.
An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device. Averse Device Effect is defined as any sign, symptom, or disease in a study subject that occurs during the course of a clinical trial that is determined by the investigator to have a causal relationship or possible causal relationship with the device under investigation.
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Infections and infestations
Kidney infection
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4.0%
1/25 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 16 week post-final follow-up visit.
An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device. Averse Device Effect is defined as any sign, symptom, or disease in a study subject that occurs during the course of a clinical trial that is determined by the investigator to have a causal relationship or possible causal relationship with the device under investigation.
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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