This is a prospective, open label, multi-center clinical study to collect additional data and imaging for the ViaSure device.The intended use of the ViaSure device used in this study is to assess the usability and tissue response to shock wave treatment.
Up to 50 subjects will be enrolled at 2 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments with the study device. Follow up visits may occur 30 and 90 days post last treatment visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Self-controlled, single-arm group using the Shockwave device.
Cynosure, Inc.
Westford, Massachusetts, United States
# of Subjects With Altered Gene Expression
Subjects had their gene expression relative to their own baseline samples analyzed using nSolver 4.0 software, and this was done 14 days post treatment.
Time frame: 14 days post treatment
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