CoolSculpting and EMS for the Abdomen

Not Applicable

Completed

• Conditions: Body Fat Disorder

• Registration Number: NCT03738891
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to CoolSculpting.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-07
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-13
• Primary Completion: 2019-09-09
• Study Completion: 2019-09-09
• Results First Submitted: 2021-11-01
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Results First Posted: 2025-05-16
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)	Baseline photos will be compared to images collected at the final 12-week post-treatment follow-up visit.	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").
Number of Unanticipated Adverse Device Effects (UADE)	Enrollment through the final 12-week follow-up visit.	The number of UADEs occurring during the study will be tabulated.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Global Aesthetic Improvement Scale (S-GAIS) Reporting Improvement	Final post-treatment 12-week follow-up visit	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.
Change in Pre-treatment and Post-treatment Abdominal Circumference	Baseline and final 12-week follow-up visit.	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.

Trial Locations

Locations (4)

Marina Plastic Surgery; 🇺🇸 Marina Del Rey, California, United States

Innovation Research Center; 🇺🇸 Pleasanton, California, United States

Laser & Skin Surgery Center of Northern California; 🇺🇸 Sacramento, California, United States

Aesthetic Solutions, P.A.; 🇺🇸 Chapel Hill, North Carolina, United States