Trial Outcomes & Findings for CoolSculpting of the Flank With Alternate Treatment Parameters (NCT NCT02081196)
NCT ID: NCT02081196
Last Updated: 2021-03-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Enrollment through 16 weeks post-treatment visit, which is approximately 5 months
Results posted on
2021-03-01
Participant Flow
Patients who seek reduction of fat in the flanks will be recruited from the general population.
Participant milestones
| Measure |
CoolSculpting Intervention
CoolSculpting treatments were performed on one (1) flank in a single treatment visit. The contralateral flank served as the untreated control.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
Untreated Control Flank
|
45
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
CoolSculpting Intervention
CoolSculpting treatments were performed on one (1) flank in a single treatment visit. The contralateral flank served as the untreated control.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
CoolSculpting of the Flank With Alternate Treatment Parameters
Baseline characteristics by cohort
| Measure |
CoolSculpting Intervention
n=45 Participants
CoolSculpting treatments were performed on one (1) flank in a single treatment visit.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Body Mass Index
|
24.1 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Enrollment through 16 weeks post-treatment visit, which is approximately 5 monthsPopulation: The safety population includes all subjects treated with CoolSculpting.
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.
Outcome measures
| Measure |
CoolSculpting of the Flank With Alternate Treatment Parameters
n=45 Participants
Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated.
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration using the Zeltiq CoolSculpting System.
|
|---|---|
|
The Number of Device and/or Procedure-Related Adverse Events
|
12 device or procedure-related AEs
|
PRIMARY outcome
Timeframe: Pre-treatment and 16 weeks post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
CoolSculpting of the Flank With Alternate Treatment Parameters
n=35 Participants
Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated.
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration using the Zeltiq CoolSculpting System.
|
|---|---|
|
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
|
-3.92 mm
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: 16 weeks post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
CoolSculpting of the Flank With Alternate Treatment Parameters
n=105 photos
Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated.
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration using the Zeltiq CoolSculpting System.
|
|---|---|
|
Proportion of Pre-treatment Images Correctly Identified.
|
89 photos
|
SECONDARY outcome
Timeframe: 16 weeks post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
CoolSculpting of the Flank With Alternate Treatment Parameters
n=43 Participants
Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated.
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration using the Zeltiq CoolSculpting System.
|
|---|---|
|
Subject Satisfaction
Procedure comfortable/very comfortable
|
21 Participants
|
|
Subject Satisfaction
Very visible to visible fat reduction
|
37 Participants
|
|
Subject Satisfaction
Positive overall effect
|
34 Participants
|
|
Subject Satisfaction
Somewhat to very different fit of clothing
|
26 Participants
|
|
Subject Satisfaction
Somewhat to very satisfied with procedure/results
|
38 Participants
|
|
Subject Satisfaction
Somewhat likely to likely to have another procedur
|
39 Participants
|
|
Subject Satisfaction
Very to somewhat likely to have same area treated
|
24 Participants
|
|
Subject Satisfaction
Would recommend procedure to a friend
|
37 Participants
|
Adverse Events
CoolSculpting of the Flank -Subjects With Systemic AEs
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Flank Treated With CoolSculpting Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
UnTreated Contralateral Flank
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CoolSculpting of the Flank -Subjects With Systemic AEs
n=45 participants at risk
Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated.
|
Flank Treated With CoolSculpting Group
n=45 participants at risk
One flank on each enrolled subject was treated with CoolSculpting.
|
UnTreated Contralateral Flank
n=45 participants at risk
Each enrolled subject had one flank that was untreated, and no intervention was used.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Prolonged numbness in treatment area
|
0.00%
0/45 • 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.
|
11.1%
5/45 • Number of events 5 • 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.
|
0.00%
0/45 • 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.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/45 • 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.
|
4.4%
2/45 • Number of events 2 • 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.
|
0.00%
0/45 • 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.
|
|
Skin and subcutaneous tissue disorders
First degree burn
|
0.00%
0/45 • 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.
|
2.2%
1/45 • Number of events 1 • 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.
|
0.00%
0/45 • 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.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous induration
|
0.00%
0/45 • 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.
|
2.2%
1/45 • Number of events 1 • 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.
|
0.00%
0/45 • 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.
|
|
General disorders
Post-treatment pain
|
0.00%
0/45 • 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.
|
6.7%
3/45 • Number of events 3 • 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.
|
0.00%
0/45 • 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.
|
|
General disorders
Cough and/or cold
|
2.2%
1/45 • Number of events 1 • 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.
|
0.00%
0/45 • 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.
|
0.00%
0/45 • 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.
|
|
Infections and infestations
Bronchitis and strep throat
|
2.2%
1/45 • Number of events 1 • 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.
|
0.00%
0/45 • 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.
|
0.00%
0/45 • 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.
|
|
Infections and infestations
Sinus infection
|
2.2%
1/45 • Number of events 1 • 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.
|
0.00%
0/45 • 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.
|
0.00%
0/45 • 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.
|
|
Infections and infestations
Influenza
|
2.2%
1/45 • Number of events 1 • 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.
|
0.00%
0/45 • 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.
|
0.00%
0/45 • 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.
|
|
General disorders
Anxiety
|
2.2%
1/45 • Number of events 1 • 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.
|
0.00%
0/45 • 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.
|
0.00%
0/45 • 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.
|
|
Musculoskeletal and connective tissue disorders
Fractured heel
|
2.2%
1/45 • Number of events 1 • 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.
|
0.00%
0/45 • 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.
|
0.00%
0/45 • 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.
|
|
General disorders
Allergic reaction
|
2.2%
1/45 • Number of events 1 • 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.
|
0.00%
0/45 • 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.
|
0.00%
0/45 • 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.
|
Additional Information
Kerrie Jiang, Executive Director, Regulatory, Clinical and Medical Affairs
Zeltiq Aesthetics
Phone: (925) 621-7462
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place