Post-Market Clinical Follow Up Study to Collect Additional Data and Imaging

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post Market Clinical Follow Up Study to Collect Additional Data and Imaging

Conditions
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Connective Tissue Defect

Intervention / Treatment
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* Device: Shockwave Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy male or female 18 - 65 years of age. Willing to undergo treatments with the SoftWave device. Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study. Understands and accepts the obligation and is logistically able to be present for all visits. Is willing to comply with all requirements of the study and sign the informed consent document. Exclusion Criteria: Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study. The subject has a pacemaker or implantable defibrillator. The subject has a severe coagulation disorder. The subject has open epiphyseal plates. The subject has recently had a steroid injection. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months to entering this study. The subject has any condition or is in a situation which, in the Investigator's opinion, may put the subject at significant risk, may

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shockwave Device<br>The Shockwave device will be used on multiple areas of the body for the purpose of treating connective tissue. | Device: Shockwave Treatment<br>* Self-controlled, single-arm group using the Shockwave device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| # 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. | 14 days post treatment |