An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

Completed

• Conditions: Uterine Fibroid; Arteriovenous Malformations; Hypervascular Tumors; Benign Prostatic Hyperplasia

• Registration Number: NCT04272216
• Lead Sponsor: Terumo Medical Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-06
• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-17
• Status Verified: 2021-10
• Primary Completion: 2022-03-07
• Study Completion: 2023-03-11
• Results First Submitted: 2024-02-29
• Results First Submitted QC: 2025-09-05
• Last Update Submitted: 2025-09-05
• Results First Posted: 2025-09-09
• Last Update Posted: 2025-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedural Success	Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure))	Defined as completing the planned procedure without femoral access bailout
Technical Success	Duration of procedure (from when the injection of HydroPearls is started until access site closure has been completed)	Delivery of HydroPearls to the target vessel and slowing the blood flow with microsphere embolization
Freedom From Major Adverse Events and Radial Access Complications	within 30 days post-procedure	Major Adverse Events are defined as the following: Death MI Stroke
Radial Access Related Complications Within 30 Days	30 days post procedure	Radial access related complications that occurred within 30 days of the index procedure include, but are not limited to, the following: Radial Artery Occlusion (RAO) Hand Ischemia Arteriovenous Fistula Pseudoaneurysm Any complication requiring surgical and/or endovascular intervention within 30 days of the index procedure

Trial Locations

Locations (6)

University of California - Los Angeles; 🇺🇸 Los Angeles, California, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

SLU Department of Radiology; 🇺🇸 St Louis, Missouri, United States

Mount Sinai; 🇺🇸 New York, New York, United States

UNC; 🇺🇸 Chapel Hill, North Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States