Micro Plug Set

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-31

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Trauma Injury Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No