An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

NCT04272216 | Completed Results FDA Device

• 1 other identifier: TIS2019-02
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Procedural Success

  Defined as completing the planned procedure without femoral access bailout

  Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure))

• Technical Success

  Delivery of HydroPearls to the target vessel and slowing the blood flow with microsphere embolization

  Duration of procedure (from when the injection of HydroPearls is started until access site closure has been completed)

• Freedom From Major Adverse Events and Radial Access Complications

  Major Adverse Events are defined as the following: Death MI Stroke

  within 30 days post-procedure

• Radial Access Related Complications Within 30 Days

  Radial access related complications that occurred within 30 days of the index procedure include, but are not limited to, the following: Radial Artery Occlusion (RAO) Hand Ischemia Arteriovenous Fistula Pseudoaneurysm Any complication requiring surgical and/or endovascular intervention within 30 days of the index procedure

  30 days post procedure

Study Arms (1)

Treatment with HydroPearl via radial access

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

Device: Treatment with HydroPearl via radial access

Interventions

Treatment with HydroPearl via radial access DEVICE

This is an observational study collecting data on patients who are already being treated with HydroPearl on-label per standard of care.

Treatment with HydroPearl via radial access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective, multi-center, registry study to assess the procedural success, technical success, and complication rate of radial access procedures using HydroPearl microspheres.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Terumo Medical Corporation: lead

Study Sites (6)

University of California - Los Angeles

Los Angeles, California, 90095, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

SLU Department of Radiology

St Louis, Missouri, 63110, United States

Location

Mount Sinai

New York, New York, 11766, United States

Location

UNC

Chapel Hill, North Carolina, 27599, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Leiomyoma; Arteriovenous Malformations; Prostatic Hyperplasia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Paige Gowen
• Organization: Clinical Project Manager

paige.gowen@terumomedical.com

908-208-3749

Study Officials

• Marcelo Guimaraes, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: February 6, 2020
• Primary Completion: March 7, 2022
• Study Completion: March 11, 2023
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)