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 three follow-up visits, 2 months, 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 magnetic resonance imaging and the subject's weight
will be recorded.
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. In addition, at the last therapy visit, subjects will receive Subject
Satisfaction and Therapy Comfort Questionnaires to fill in.
Post-procedure evaluation (follow-up visits) will be conducted 2, 6 and 12 months after the
final treatment. During those visits, magnetic resonance imaging, photographing and weight
measure will be conducted. Subject Satisfaction Questionnaire will be given at every
follow-up visit.
n/a
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