Muscle Tightness Clinical Trial
Official title:
Safety and Patient Satisfaction With Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Aesthetic Improvements of Buttocks
This study will evaluate the clinical safety and patient satisfaction with the high power
magnet system for the aesthetic improvement of buttocks. 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 - 1 month, 3 months and 12 months after the final treatment. Study will be
conducted at several study sites.
At the baseline visit, subject's weight will be recorded.
The treatment administration phase will consist of four (4) treatments, delivered twice a
week. The applicator will be applied over the gluteal area. Visible contractions will be
induced by the device.
At the last therapy visit, the subject's weight will be recorded. In addition, subjects will
receive Subject Satisfaction Questionnaire 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 months and 12
months after the final treatment. A weight measure will be conducted. Also, subject's
satisfaction will be noted.
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