N/A
Completed N=99
An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres
Uterine Fibroid · Arteriovenous Malformations · Hypervascular Tumors · Benign Prostatic Hyperplasia
Source: ClinicalTrials.gov NCT04272216 ↗
Enrolled (actual)
99
Serious AEs
9.1%
Results posted
Sep 2025
Primary outcomePrimary: Procedural Success — 70; 16; 7; 6 Participants
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.
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 | — |
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.
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. Informational only — not medical advice.