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

• Conditions: Trauma Injury; Bleeding

• Registration Number: NCT04218292
• Lead Sponsor: KA Medical, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-06
• Study Start: 2020-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of serious device-related and procedure-related adverse events	12 months	Rate of serious device-related and procedure-related adverse events

Secondary Outcome Measures

Name	Time	Method
Rate of successful delivery of the device	1 day	Rate of successful delivery of the Micro Plug device to the intended position.

Trial Locations

Locations (1)

University Hospital Magdeburg; 🇩🇪 Magdeburg, Germany