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NCT04218292 Clinical Trial

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

Bleeding Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04218292
Other study ID # PMCF 24October2019
Secondary ID KAM-P4-21-01
Status Active, not recruiting
Phase
First received
Last updated
Start date March 31, 2020
Est. completion date February 28, 2022

Study information
Verified date April 2021
Source KA Medical, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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 Micro Plug Set Instructions For Use.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany University Hospital Magdeburg Magdeburg

Sponsors (2)
Lead Sponsor Collaborator
KA Medical, LLC Merit Medical Systems, Inc.

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of serious device-related and procedure-related adverse events Rate of serious device-related and procedure-related adverse events 12 months
Secondary Rate of successful delivery of the device Rate of successful delivery of the Micro Plug device to the intended position. 1 day
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