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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Bleeding; Trauma Injury
• Intervention / Treatment: Device: Micro Plug Set

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Germany
  • Magdeburg, Germany, 39120
    • University Hospital Magdeburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring routine standard of care for peripheral embolization. Some of the patients will be liver cancer patients undergoing palliative treatment with SIRT who have a life expectancy that may be less than 12 months. Other patients may be treated for trauma or bleeding.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of serious device-related and procedure-related adverse events	Rate of serious device-related and procedure-related adverse events	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful delivery of the device	Rate of successful delivery of the Micro Plug device to the intended position.	1 day

Collaborators and Investigators

• Sponsor: KA Medical, LLC
• Collaborators: Merit Medical Systems, Inc.
• Investigators: Principal Investigator: Maciej Pech, MD, University Hospital Magdeburg, Germany

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2020
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PMCF 24October2019; KAM-P4-21-01 (Other Identifier: Merit Medical Systems, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes