TYPE AND DESIGN OF STUDY Sample Clauses

TYPE AND DESIGN OF STUDY. This study is a prospective, multi-center, non-randomized clinical trial. Up to 20 subjects who are naïve to Ultherapy for treatment of hyperhidrosis will be enrolled if all entrance criteria are met confirming eligibility for study treatment. Subjects will be treated using the Ulthera® System by the study investigator, sub-investigator or delegated clinician, receiving treatment in a 3 x 4 grid, 12 treatment squares, 60 lines of treatment per square, at one treatment depth (3.0mm), at 0.30 J of energy. Ultrasound images will be captured of each axilla prior to the first study treatment to assess dermal thickness and depth of sweat glands. A gravimetric measurement of sweat production, starch iodine test, and pregnancy screening test, if applicable, will be performed prior to each study treatment. Digital images of the starch iodine test will be obtained. HDSS scores will be obtained prior to each treatment. During treatment, the average Numeric Rating Scale (NRS) score will be obtained by axilla treated. Following the completion of study treatment(s), follow-up visits will be at 30, and 90 days post-treatment to assess safety and efficacy. Gravimetric sweat production measures and starch iodine tests will be completed at treatment visit #2 and at all follow-ups for all study groups. Digital images of the starch iodine test will be obtained. HDSS scores will be obtained at the treatment visit(s) and at all follow-ups for all study groups. Efficacy will be determined by HDSS score reduction from a 3 or 4 at baseline to a 1 or 2 at 30 days post-treatment. Subject Gravimetric results, Starch iodine results, and HDSS scores at all follow-ups will also be analyzed as secondary outcomes.
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