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

KA Medical

Status: Unknown

Conditions: Trauma Injury; Bleeding

Treatments: Device: Micro Plug Set

Study type: Observational

Funder types: Industry

Identifiers

NCT04218292

KAM-P4-21-01 (Other Identifier)

PMCF 24October2019

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.