An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres (RAVI Registry)

Terumo

Status: Completed

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

Treatments: Device: Treatment with HydroPearl via radial access

Study type: Observational

Funder types: Industry

Identifiers

NCT04272216

TIS2019-02

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

99 participants in 1 patient group

Treatment with HydroPearl via radial access

Description:

all patients will be in the same group/cohort in this open-label, single-arm, observational registry.

Treatment:

Device: Treatment with HydroPearl via radial access