Evaluate the safety and efficacy of magnetic muscle stimulation (MMS) of abdominal muscle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
16
The MMS device will be used to perform the treatments.
Innovation Research Center
Pleasanton, California, United States
Change in Body Satisfaction Questionnaire From Baseline to 1-month Post-Treatment Follow-up Visit
Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ) at the 1-month 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). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 1-month post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score.
Time frame: Baseline, 1-month 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 3-months following the final treatment (approximately 4 months).
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