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

  • STATUS
    Recruiting
  • days left to enroll
    52
  • participants needed
    50
  • sponsor
    Cynosure, Inc.
Updated on 28 July 2022

Summary

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.

Description

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.

Details
Condition Connective Tissue Defect
Treatment Shockwave Treatment
Clinical Study IdentifierNCT04880070
SponsorCynosure, Inc.
Last Modified on28 July 2022

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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