EMS for Abdominal and Gluteal Muscle Toning
- Conditions
- Non-Therapeutic Body Modification
- Interventions
- Device: The ZELTIQ System
- Registration Number
- NCT03983304
- Lead Sponsor
- Zeltiq Aesthetics
- Brief Summary
Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.
- Detailed Description
The safety and effectiveness of an Electromagnetic Muscle Stimulation device when used for abdominal and gluteal toning will be evaluated in this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Muscle Toning The ZELTIQ System The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen and buttocks.
- Primary Outcome Measures
Name Time Method Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit Baseline, 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.
Number of Incidents of Device-Related Adverse Events AE information will be collected from the time of enrollment to the final follow-up visit at 12 weeks following the final treatment. The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS) 4-week post-treatment follow-up visit 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".
Trial Locations
- Locations (8)
Innovation Research Center
🇺🇸Pleasanton, California, United States
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
Bowes Dermatology by Riverchase
🇺🇸Miami, Florida, United States
Marina Plastic Surgery
🇺🇸Marina Del Rey, California, United States
Cosmetic Laser Dermatology
🇺🇸San Diego, California, United States
EpiCentre Park Lane
🇺🇸Dallas, Texas, United States