N/A N=99

An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

Uterine Fibroid · Arteriovenous Malformations · Hypervascular Tumors · Benign Prostatic Hyperplasia

Bottom Line

View on ClinicalTrials.gov: NCT04272216 ↗

Enrolled (actual)

Serious AEs

9.1%

Results posted

Sep 2025

Primary outcome: Primary: Procedural Success — 70; 16; 7; 6 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Treatment with HydroPearl via radial access (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Terumo Medical Corporation
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Procedural Success	70; 16; 7; 6	—
PRIMARY Technical Success	69; 16; 7; 6; 69; 14	—
PRIMARY Freedom From Major Adverse Events and Radial Access Complications	69; 16; 6; 6; 1; 0	—
PRIMARY Radial Access Related Complications Within 30 Days	0; 0; 0; 0; 0; 0	—

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 Criteria

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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04272216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.