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Real-World data on HydroPearl embolization through the wrist

NCT ID NCT04272216

Knowledge-focused Sponsor: Terumo Medical Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This completed registry study collected real-world data on 99 patients receiving HydroPearl microspheres to block blood flow to conditions like uterine fibroids, arteriovenous malformations, hypervascular tumors, and benign prostatic hyperplasia. The procedure was done through the radial artery in the wrist instead of the groin. The goal was to measure how often the procedure succeeded and how often complications occurred.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HydroPearl microspheres
What this could lead to
If successful, this registry could confirm that radial access embolization with HydroPearl is safe and effective in routine practice, supporting its wider use.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection or other factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

99 people

The number who actually took part.

Started

Feb 2020

Finished

Mar 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

arteriovenous hemangioma/malformation arteriovenous malformations of the brain benign prostatic hyperplasia leiomyoma uterine corpus leiomyoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arteriovenous malformations Benign prostatic hyperplasia Hypervascular tumors Uterine fibroid

Contacts and locations

Locations

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mount Sinai

    New York, New York, 11766, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • SLU Department of Radiology

    St Louis, Missouri, 63110, United States

  • UNC

    Chapel Hill, North Carolina, 27599, United States

  • University of California - Los Angeles

    Los Angeles, California, 90095, United States

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