Fat Burn Clinical Trial
Official title:
Safety and Efficacy of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Fat Disruption of the Abdomen
The study is a prospective multi-center open-label single-arm study. The subjects will be
enrolled and assigned into a single study group. Subjects will be required to complete four
(4) treatment visits and four follow-up visits, 1 month, 3, 6 and 12 months after the final
treatment.
At the baseline visit, photographs of the abdomen will be taken. In addition, adipose/muscle
layer thickness will be measured with the computed tomography and the subject's weight will
be recorded. In addition, at the last therapy visit, subjects will receive Subject
Satisfaction and Therapy Comfort Questionnaires to fill in.
Safety measures will include documentation of adverse events (AE) including subject's
experience of pain or discomfort after the procedure. Following each treatment administration
and at the follow-up visits, subjects will be checked for immediate post-procedure adverse
event assessment.
Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3, 6 and 12 months
after the final treatment. Computed tomography and weight measure will be conducted at every
follow-up visit. Also, subject's satisfaction will be noted. During the first (1 month),
third (6 months) and last (12 months) follow-up visits, photographs of abdomen will be taken.
n/a
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