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

NCT04880070 | Completed Results FDA Device

• 1 other identifier: SW-MCPM-2021
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Connective Tissue Defect

Outcome Measures

Primary Outcomes (1)

• # 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

Study Arms (1)

Shockwave Device

EXPERIMENTAL

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

Device: Shockwave Treatment

Interventions

Shockwave Treatment DEVICE

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

Shockwave Device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

Cynosure, Inc.

Westford, Massachusetts, 01886, United States

Location

Related Publications (1)

• Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

  PMID: 31896400 BACKGROUND

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

(978) 256-4200

Study Officials

• Jennifer Civiok

  Cynosure, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 10, 2021
• Study Start: March 12, 2021
• Primary Completion: May 11, 2021
• Study Completion: May 11, 2021
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-06

Locations

US (1)