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Dr. Amplatz Micro Plug - Post Market Clinical Follow-up (PMCF) Plan

Dr. Amplatz Micro Plug - Post Market Clinical Follow-up (PMCF) Plan

Recruiting
18 years and older
All
Phase N/A

Overview

This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Dr. Amplatz Micro Plug 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.

Eligibility

Inclusion Criteria:

  • Subject is scheduled for arterial embolization in the peripheral vasculature.
  • Subject is greater than 18 years of age

Exclusion Criteria:

  • Subject is unable to give informed consent
  • Subject is pregnant or breastfeeding
  • Subject has allergy to nickel
  • Patient requires neurologic or cardiac use of an occlusion device, contrary to the Dr. Amplatz Micro Plug Instructions For Use.

Study details
    Hemorrhage
    Hemorrhage
    Trauma Injury

NCT04218292

KA Medical, LLC

16 February 2024

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