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

NCT04880070 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-06-15

Study results available
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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

Interventions

DEVICE

Shockwave Treatment

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

Sponsors & Collaborators

  • Cynosure, Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Civiok · Cynosure, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2021-05-11
Completion
2021-05-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04880070 on ClinicalTrials.gov