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

NCT ID: NCT04880070

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-12
• Study Completion Date: 2021-05-11

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.

Detailed 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.

Conditions

Connective Tissue Defect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Shockwave Device

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

Group Type: EXPERIMENTAL

Shockwave Treatment

Intervention Type: DEVICE

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

Interventions

Shockwave Treatment

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cynosure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Civiok

Role: STUDY_DIRECTOR

Cynosure, Inc.

Locations

Cynosure, Inc.

Westford, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31896400 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SW-MCPM-2021

Identifier Type: -

Identifier Source: org_study_id