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Micro Plug Set - Post Market Clinical Follow-up (PMCF) Plan

NCT04218292 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-04-23

No results posted yet for this study

Summary

This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Micro Plug Set which is intended for use during arterial embolization of the peripheral vasculature. This PMCF will collect data pertaining to any adverse events as well as the identification of any unanticipated risks up to the first 12 months following device implant.

Conditions

Interventions

DEVICE

Micro Plug Set

The Micro Plug Set is indicated for arterial embolization in the peripheral vasculature.

Sponsors & Collaborators

  • Merit Medical Systems, Inc.

    collaborator INDUSTRY

  • KA Medical, LLC

    lead INDUSTRY

Principal Investigators

  • Maciej Pech, MD · University Hospital Magdeburg, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2022-02-28
Completion
2022-02-28
FDA Device
Yes

Countries

  • Germany

Study Locations

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Entities

Diseases

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 NCT04218292 on ClinicalTrials.gov