An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

Completed

• Conditions: Uterine Fibroid; Arteriovenous Malformations; Hypervascular Tumors; Benign Prostatic Hyperplasia
• Interventions: Device: Treatment with HydroPearl via radial access

• 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
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-10

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

Arm && Interventions

Group	Intervention	Description
Treatment with HydroPearl via radial access	Treatment with HydroPearl via radial access	all patients will be in the same group/cohort in this open-label, single-arm, observational registry.

Primary Outcome Measures

Name	Time	Method
Technical Success	End of procedure	delivery of HydroPearl to the target vessel and slowing the blood flow with microsphere embolization
Procedural Success	During procedure	defined as completing the planned procedure without femoral access bailout
Freedom from major adverse events and radial access complications	within 30 days post-procedure

Trial Locations

Locations (6)

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

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

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

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

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

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