Status unknownNCT04218292Updated Apr 23, 2021

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

An observational study in Trauma Injury and Bleeding, sponsored by KA Medical, LLC. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-23.

Sponsored by KA Medical, LLC · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Active, not recruiting — may be out of date.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 40
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Trauma Injury
Bleeding

In context

Lead sponsor

This is the only study on the registry with KA Medical, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
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.

Inclusion criteria

Subject is scheduled for arterial embolization in the peripheral vasculature.
Subject is greater than 18 years of age

Exclusion criteria

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

Observational model: Cohort
Time perspective: Prospective
Enrollment: 40 participants (actual)
Patient registry: No

Interventions

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

What researchers measure

Primary outcomes

Rate of serious device-related and procedure-related adverse events
Rate of serious device-related and procedure-related adverse events
Time frame: 12 months

Secondary outcomes

Rate of successful delivery of the device
Rate of successful delivery of the Micro Plug device to the intended position.
Time frame: 1 day

Study locations

1 site

University Hospital Magdeburg
Magdeburg, 39120, Germany

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04218292
Lead sponsor: KA Medical, LLC
Collaborators: Merit Medical Systems, Inc.
Responsible party: Sponsor
First posted: Jan 6, 2020
Start date: Mar 31, 2020
Primary completion: Feb 28, 2022 (estimated)
Completion: Feb 28, 2022 (estimated)
Last update: Apr 23, 2021

Study contacts

Maciej Pech, MD

principal investigator · University Hospital Magdeburg, Germany

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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