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

Overseen By Jamie Trimper

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cynosure, Inc.

Disqualifiers: Pregnancy, Pacemaker, Coagulation disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: Varies

5 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the purpose of this trial?

This trial is testing the ViaSure device, which uses shock waves to help heal tissues. Up to 50 participants will be involved across two locations. The study will check how well the device works and how tissues respond to the treatment. Participants may receive up to five treatments and will have follow-up visits for a few months after their last treatment. Shock wave therapy has been used in various medical treatments, including for rotator cuff disease and low back pain, but its efficacy and safety remain uncertain.

Research Team

Jennifer Civiok

Principal Investigator

Cynosure, Inc.

Eligibility Criteria

Inclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive up to 5 treatments with the ViaSure device

Varies

Up to 5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

2 visits (in-person)

Treatment Details

Interventions

• ViaSure device

Participant Groups

Group I: Shockwave Device Experimental Treatment 1 Intervention

The Shockwave device will be used on multiple areas of the body for the purpose of treating connective tissue.

Who Is Running the Clinical Trial?

Cynosure, Inc.

Lead Sponsor

Trials

52

Recruited

1,200+