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

KA Medical, LLC40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Trauma Injury Bleeding

Interventions

Micro Plug SetDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Micro Plug Set Instructions For Use.

Locations (1)

University Hospital Magdeburg

Magdeburg, Germany

Outcomes

Primary Outcomes

Rate of serious device-related and procedure-related adverse events

Time frame: 12 months

Secondary Outcomes

Rate of successful delivery of the device

Rate of successful delivery of the Micro Plug device to the intended position.

Time frame: 1 day

Data from ClinicalTrials.gov

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