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NCT04272216 Clinical Trial

An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

Benign Prostatic Hyperplasia Clinical Trial

— RAVI Registry  

Official title:
The RAVI Registry: A Prospective, Multi-Center, Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04272216
Other study ID # TIS2019-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 6, 2020
Est. completion date March 11, 2023

Study information
Verified date October 2021
Source Terumo Medical Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date March 11, 2023
Est. primary completion date March 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Treatment with HydroPearl via radial access
This is an observational study collecting data on patients who are already being treated with HydroPearl on-label per standard of care.

Locations
Country Name City State
United States UNC Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Rush University Medical Center Chicago Illinois
United States University of California - Los Angeles Los Angeles California
United States Mount Sinai New York New York
United States SLU Department of Radiology Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Terumo Medical Corporation

Country where clinical trial is conducted

United States, 

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