Trial Outcomes & Findings for CoolSculpting and EMS for the Abdomen (NCT NCT03738891)
NCT ID: NCT03738891
Last Updated: 2025-05-16
Results Overview
The number of UADEs occurring during the study will be tabulated.
COMPLETED
NA
50 participants
Enrollment through the final 12-week follow-up visit.
2025-05-16
Participant Flow
A total of 50 participants enrolled into Cohorts 1, 2, and 3. One subject enrolled in Cohort 3, received the treatment and completed all follow-up visits per Cohort 3 before subsequently rolling over to, and receiving treatment planned for Cohort 4. No other subjects were enrolled in Cohort 4. Efficacy data for Cohort 4 was excluded from analysis to avoid the perception of enhancing study enrollment. Data from this participant's treatment in Cohort 3 was included in all endpoint analyses.
Participant milestones
| Measure |
Cohort 1-EMS Only
Participants in this group were treated with 4 sessions of Electromagnetic Muscle Stimulation (EMS). CoolSculpting was not used.
|
Cohort 2 - EMS Followed by CoolSculpting
Participants were treated with EMS (4 sessions) followed by 1 CoolSculpting treatment (3-6 cooling cycles)
|
Cohort 3 - CoolSculpting Only
Participants were treated with 1 CoolSculpting treatment (3-6 cooling cycles)
|
Cohort 4
Participants were treated with 1 CoolSculpting treatment (3-6 cooling cycles) followed by 4 sessions of EMS.
|
|---|---|---|---|---|
|
Initial Cohort Assignment
STARTED
|
20
|
20
|
10
|
0
|
|
Initial Cohort Assignment
COMPLETED
|
20
|
20
|
10
|
0
|
|
Initial Cohort Assignment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Subsequent Cohort Assignment
STARTED
|
0
|
0
|
0
|
1
|
|
Subsequent Cohort Assignment
COMPLETED
|
0
|
0
|
0
|
1
|
|
Subsequent Cohort Assignment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CoolSculpting and EMS for the Abdomen
Baseline characteristics by cohort
| Measure |
Cohort 1-EMS Only
n=20 Participants
Participants in this group were treated with 4 sessions of Electromagnetic Muscle Stimulation (EMS). CoolSculpting was not used.
|
Cohort 2 - EMS Followed by CoolSculpting
n=20 Participants
articipants were treated with EMS (4 sessions) followed by 1 CoolSculpting treatment (3-6 cooling cycles)
|
Cohort 3 - CoolSculpting Only
n=10 Participants
Participants were treated with 1 CoolSculpting treatment (3-6 cooling cycles)
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
42.2 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Am. Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pac Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Body Mass Index
|
22.6 kg/m^2
STANDARD_DEVIATION 2.1 • n=5 Participants
|
24.1 kg/m^2
STANDARD_DEVIATION 2.3 • n=7 Participants
|
23.9 kg/m^2
STANDARD_DEVIATION 2.1 • n=5 Participants
|
23.5 kg/m^2
STANDARD_DEVIATION 2.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: Enrollment through the final 12-week follow-up visit.Population: All Participants who received at least one study treatment. Participants in all cohorts were evaluated for adverse events.
The number of UADEs occurring during the study will be tabulated.
Outcome measures
| Measure |
Cohort 1-EMS Only
n=20 Participants
Participants in this group were treated with 4 sessions of Electromagnetic Muscle Stimulation (EMS). CoolSculpting was not used.
|
Cohort 2 - EMS and CoolSculpting
n=20 Participants
Following 4 sessions of EMS, participants received 3-6 cycles of CoolSculpting.
|
Cohort 3 - CoolSculpting Only
n=10 Participants
Participants in this arm received 3-6 cycles of CoolSculpting treatments.
|
Cohort 4 - CoolSculpting Followed by EMS
n=1 Participants
Following 3-6 cycles of CoolSculpting treatments, participants were treated with 4 sessions of EMS.
Cohort 4 included a single subject who was rolled over after completing Cohort 3 study activities.
|
|---|---|---|---|---|
|
Number of Unanticipated Adverse Device Effects (UADE)
|
0 events
|
0 events
|
0 events
|
0 events
|
PRIMARY outcome
Timeframe: Baseline photos will be compared to images collected at the final 12-week post-treatment follow-up visit.Population: All enrolled participants in Cohort 1 were included in the efficacy analysis. Cohort 2 excluded 1 participant for weight outside of protocol requirements and 1 subject for lack of 12-week follow-up photos. Cohort 3 excluded 1 participant due to a surgical procedure in the treatment area. Cohort 4 excluded one participant previously enrolled and treated in Cohort 3 (allowed per protocol); participant included in Cohort 3 analysis only.
Comparison of pre-treatment- and 12-week post-final treatment photographs by independent physician reviewer. The reviewer was blinded to the method of treatment and study cohort; baseline and 12-week post-treatment photos were not blinded. After Sponsor training, the reviewer entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved ("Very Much Improved," "Much Improved", and "Improved").
Outcome measures
| Measure |
Cohort 1-EMS Only
n=20 Participants
Participants in this group were treated with 4 sessions of Electromagnetic Muscle Stimulation (EMS). CoolSculpting was not used.
|
Cohort 2 - EMS and CoolSculpting
n=18 Participants
Following 4 sessions of EMS, participants received 3-6 cycles of CoolSculpting.
|
Cohort 3 - CoolSculpting Only
n=9 Participants
Participants in this arm received 3-6 cycles of CoolSculpting treatments.
|
Cohort 4 - CoolSculpting Followed by EMS
Following 3-6 cycles of CoolSculpting treatments, participants were treated with 4 sessions of EMS.
Cohort 4 included a single subject who was rolled over after completing Cohort 3 study activities.
|
|---|---|---|---|---|
|
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)
|
16 Participants
|
16 Participants
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and final 12-week follow-up visit.Population: There were no exclusions from efficacy analysis in Cohort 1. One (1) participant in Cohort 2 was excluded from the analysis due to weight outside requirements of the protocol; 1 participant from cohort 3 was excluded due to a surgical treatment; cohort 4 consisted of a single participant treated in cohort 3 and subsequently rolled over to cohort 4 after cohort 3 final follow-up was completed. Cohort 4 was therefore not analyzed for efficacy.
Abdominal circumference as measured by 3-Dimensional imaging prior to treatment (baseline) is compared to images collected at the final 12-week post-treatment follow-up visit. Measurements were captured at 3 points including the upper, middle and lower abdomen. All measurements were averaged per subject at the baseline and 12-week visit time points to obtain circumference values. Results for each cohort are shown in millimeters of circumference reduction.
Outcome measures
| Measure |
Cohort 1-EMS Only
n=20 Participants
Participants in this group were treated with 4 sessions of Electromagnetic Muscle Stimulation (EMS). CoolSculpting was not used.
|
Cohort 2 - EMS and CoolSculpting
n=19 Participants
Following 4 sessions of EMS, participants received 3-6 cycles of CoolSculpting.
|
Cohort 3 - CoolSculpting Only
n=9 Participants
Participants in this arm received 3-6 cycles of CoolSculpting treatments.
|
Cohort 4 - CoolSculpting Followed by EMS
Following 3-6 cycles of CoolSculpting treatments, participants were treated with 4 sessions of EMS.
Cohort 4 included a single subject who was rolled over after completing Cohort 3 study activities.
|
|---|---|---|---|---|
|
Change in Pre-treatment and Post-treatment Abdominal Circumference
|
-4 mm
Standard Deviation 16
|
-15 mm
Standard Deviation 11
|
-10 mm
Standard Deviation 18
|
—
|
SECONDARY outcome
Timeframe: Final post-treatment 12-week follow-up visitPopulation: All enrolled subjects with a completed S-GAIS at post-treatment 12-week follow-up visit. Cohort 4 was not included in the tabulation as the single subject treated in this cohort had been previously treated in Cohort 3 (allowed per protocol). Results for the single subject treated in both Cohort 3 and Cohort 4 were tabulated with Cohort 3.
Subjects completed a graded 7-point GAIS at 12-week post-final treatment follow-up. The scale consists of the following response options: 3 = Very much improved; 2 = Much improved; 1 = Improved; 0 = No change; -1 = Worse; -2 = Much worse; -3 = Very much worse. Results were tabulated across the three treatment cohorts. Results were calculated in the percentage of the subjects reporting improvement.
Outcome measures
| Measure |
Cohort 1-EMS Only
n=20 Participants
Participants in this group were treated with 4 sessions of Electromagnetic Muscle Stimulation (EMS). CoolSculpting was not used.
|
Cohort 2 - EMS and CoolSculpting
n=19 Participants
Following 4 sessions of EMS, participants received 3-6 cycles of CoolSculpting.
|
Cohort 3 - CoolSculpting Only
n=9 Participants
Participants in this arm received 3-6 cycles of CoolSculpting treatments.
|
Cohort 4 - CoolSculpting Followed by EMS
Following 3-6 cycles of CoolSculpting treatments, participants were treated with 4 sessions of EMS.
Cohort 4 included a single subject who was rolled over after completing Cohort 3 study activities.
|
|---|---|---|---|---|
|
Percentage of Participants With Global Aesthetic Improvement Scale (S-GAIS) Reporting Improvement
|
70 percentage of participants
Interval 46.0 to 88.0
|
89 percentage of participants
Interval 67.0 to 99.0
|
100 percentage of participants
Interval 66.0 to 100.0
|
—
|
Adverse Events
Cohort 1-EMS Only
Cohort 2 - EMS Followed by CoolSculpting
Cohort 3 - CoolSculpting Only
Cohort 4 - CoolSculpting Followed by EMS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1-EMS Only
n=20 participants at risk
Participants in this group were treated with 4 sessions of Electromagnetic Muscle Stimulation (EMS). CoolSculpting was not used.
|
Cohort 2 - EMS Followed by CoolSculpting
n=20 participants at risk
Following 4 sessions of EMS, participants received 3-6 cycles of CoolSculpting.
|
Cohort 3 - CoolSculpting Only
n=10 participants at risk
Participants in this arm received 3-6 cycles of CoolSculpting treatments.
|
Cohort 4 - CoolSculpting Followed by EMS
n=1 participants at risk
Following 3-6 cycles of CoolSculpting treatments, participants were treated with 4 sessions of EMS
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Planned hysterectomy
|
0.00%
0/20 • Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.
|
0.00%
0/20 • Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.
|
10.0%
1/10 • Number of events 1 • Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.
|
0.00%
0/1 • Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.
|
5.0%
1/20 • Number of events 1 • Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.
|
0.00%
0/10 • Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.
|
0.00%
0/1 • Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.
|
|
General disorders
Cold virus
|
0.00%
0/20 • Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.
|
5.0%
1/20 • Number of events 1 • Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.
|
0.00%
0/10 • Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.
|
0.00%
0/1 • Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.
|
Additional Information
Lori Brandt, Director, Clinical Trial Management
Zeltiq Aesthetics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place