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CoolSculpting and EMS for the Abdomen
NA trial testing Zeltiq CoolSculpting System alone in Body Fat Disorder in 50 participants. Completed in 9 September 2019.
| Lead sponsor | Zeltiq Aesthetics |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 50 |
| Start date | 7 November 2018 |
| Primary completion | 9 September 2019 |
| Estimated completion | 9 September 2019 |
| Sites | 4 locations across United States |
Zeltiq Aesthetics — full company profile →
Adults 22 to 65, any sex, with Body Fat Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The number of UADEs occurring during the study will be tabulated.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1-EMS Only | 0 | |
| Cohort 2 - EMS and CoolSculpting | 0 | |
| Cohort 3 - CoolSculpting Only | 0 | |
| Cohort 4 - CoolSculpting Followed by EMS | 0 |
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 par
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1-EMS Only | 16 | |
| Cohort 2 - EMS Followed by CoolSculpting | 16 | |
| Cohort 3 - CoolSculpting Only | 8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1-EMS Only | -4 | ± 16 |
| Cohort 2 - EMS Followed by CoolSculpting | -15 | ± 11 |
| Cohort 3 - CoolSculpting Only | -10 | ± 18 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 - Electromagnetic Muscle Stimulation (EMS) Only | 70 | 46 – 88 |
| Cohort 2 - Electromagnetic Muscle Stimulation (EMS) Followed by CoolSculpting | 89 | 67 – 99 |
| Cohort 3 - CoolSculpting Only | 100 | 66 – 100 |
Time frame: Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort 1-EMS Only | Cohort 2 - EMS Followed by… | Cohort 3 - CoolSculpting O… | Cohort 4 - CoolSculpting F… |
|---|---|---|---|---|---|
| Planned hysterectomy | Reproductive system and breast disorders | — | — | — | — |
| Influenza | Infections and infestations | — | — | — | — |
| Cold virus | General disorders | — | — | — | — |
Data from ClinicalTrials.gov NCT03738891 adverse events section.
Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to CoolSculpting.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03738891.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing