Status:

COMPLETED

An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

Lead Sponsor:

Terumo Medical Corporation

Conditions:

Uterine Fibroid

Arteriovenous Malformations

Eligibility:

All Genders

18+ years

Brief Summary

This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.

Eligibility Criteria

Inclusion

  • Subject is ≥ 18 years old
  • Subject is scheduled for a procedure for treatment with HydroPearl microspheres using radial access.
  • Subject is willing and able to complete follow-up requirements
  • Subject is willing and able to sign a written Informed Consent form prior to participating in the registry.

Exclusion

  • Unable to have a procedure with radial access for any reason.
  • Participating in another clinical study which, in the opinion of the investigator, could impact the results of this registry.
  • Pregnant or planning to become pregnant during the study.

Key Trial Info

Start Date :

February 6 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 11 2023

Estimated Enrollment :

99 Patients enrolled

Trial Details

Trial ID

NCT04272216

Start Date

February 6 2020

End Date

March 11 2023

Last Update

September 9 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

University of California - Los Angeles

Los Angeles, California, United States, 90095

2

Rush University Medical Center

Chicago, Illinois, United States, 60612

3

SLU Department of Radiology

St Louis, Missouri, United States, 63110

4

Mount Sinai

New York, New York, United States, 11766