Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to CoolSculpting.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
50
The CoolSculpting System will be used to perform the treatments in Cohort 3.
The EMS device(s) alone are used in Cohort 1.
Cohort 2 group will be treated with EMS followed by CoolSculpting
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
Number of Unanticipated Adverse Device Effects (UADE)
The number of UADEs occurring during the study will be tabulated.
Time frame: Enrollment through the final 12-week follow-up visit.
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)
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").
Time frame: Baseline photos will be compared to images collected at the final 12-week post-treatment follow-up visit.
Change in Pre-treatment and Post-treatment Abdominal Circumference
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.
Time frame: Baseline and final 12-week follow-up visit.
Percentage of Participants With Global Aesthetic Improvement Scale (S-GAIS) Reporting Improvement
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.
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Cohort 4 will be treated first with CoolSculpting, followed by EMS.
Time frame: Final post-treatment 12-week follow-up visit