Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.
The safety and effectiveness of an Electromagnetic Muscle Stimulation device when used for abdominal and gluteal toning will be evaluated in this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
110
The Zeltiq EMS device will be used to perform treatments for abdominal and gluteal toning.
Marina Plastic Surgery
Marina del Rey, California, United States
Innovation Research Center
Pleasanton, California, United States
Cosmetic Laser Dermatology
San Diego, California, United States
Bowes Dermatology by Riverchase
Miami, Florida, United States
Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit
Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ)at the 4-Week post-treatment follow-up visit. The scale measures body image using a set of dichotomous items used to describe aspects of shape and appearance. The questionnaire has total score range from 10 to 50. An increase in score (when compared to baseline) reflects the participant's perceived improvement in appearance in the treated region(abdomen or buttocks). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 4-week post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score.
Time frame: Baseline, 4-week post-treatment follow-up visit
Number of Incidents of Device-Related Adverse Events
The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.
Time frame: AE information will be collected from the time of enrollment to the final follow-up visit at 12 weeks following the final treatment.
Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS)
Subject-graded improvement in the treated area using the Subject Global Aesthetic Scale (SGAIS) at the 4-Week follow-up visit. In this study, subjects completed the SGAIS questionnaire for each treated area (e.g. a abdomen-specific questionnaire and a buttocks-specific questionnaire) at the 4-week post-final follow-up visit. Subjects were asked to rate improvement in treated areas using the following 7 point scale: 3 = Very much improved, 2 = Much improved, 1 = Improved, 0 = No change, -1 = Worse, -2 = Much worse and -3 = Very much worse. Subjects who reported 'Very Much Improved,' 'Much Improved,' and 'Improved will be categorized as 'Improved'. Results were calculated as the percentage of subjects reporting "Improved".
Time frame: 4-week post-treatment follow-up visit
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The Wall Center for Plastic Surgery
Shreveport, Louisiana, United States
Capital Laser & Skin Care
Chevy Chase, Maryland, United States
SkinCare Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, United States
EpiCentre Park Lane
Dallas, Texas, United States