Post-Market Clinical Follow Up Study to Collect Additional Data and Imaging
Completed · Not applicable
Conditions studied: Connective Tissue Defect
In brief
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.
Key facts
- Study ID
- NCT04880070
- Run by
- Cynosure, Inc.
- People needed
- 5
- Starts
- 2021-03-12
- Expected to finish
- 2021-05-11
- Last updated by the study team
- 2023-06-15
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Cynosure, Inc. — Westford, Massachusetts, United States
Full record on ClinicalTrials.gov
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