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OpenTrials
Completed

NCT Number: NCT04880070

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

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.

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Key information

Conditions

Connective Tissue Defect

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cynosure, Inc.

Westford, Massachusetts, 01886, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shockwave treatment

Device

Self-controlled, single-arm group using the Shockwave device.

Primary outcomes

  1. # of Subjects With Altered Gene Expression

    Time frame: 14 days post treatment

    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.

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 10, 2021
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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