NCT04218292

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 31, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

January 2, 2020

Last Update Submit

April 21, 2021

Conditions

Trauma InjuryBleeding

Outcome Measures

Primary Outcomes (1)

  • Rate of serious device-related and procedure-related adverse events

    Rate of serious device-related and procedure-related adverse events

    12 months

Secondary Outcomes (1)

  • Rate of successful delivery of the device

    1 day

Interventions

Micro Plug SetDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Magdeburg

Magdeburg, 39120, Germany

Location

MeSH Terms

Conditions

Accidental InjuriesHemorrhage

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maciej Pech, MD

    University Hospital Magdeburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 6, 2020

Study Start

March 31, 2020

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

April 23, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)