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

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    KA Medical, LLC
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Updated on 19 February 2024
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Summary

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.

Details
Condition Hemorrhage, Hemorrhage, Trauma Injury
Age 18years - 100years
Treatment Dr. Amplatz Micro Plug
Clinical Study IdentifierNCT04218292
SponsorKA Medical, LLC
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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