CompletedNot Applicable

An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

United States99 participantsStarted 2020-02-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Procedural Success

Timeframe: 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

Timeframe: 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

Timeframe: within 30 days post-procedure

Radial Access Related Complications Within 30 Days

Timeframe: 30 days post procedure

Trial details

NCT IDNCT04272216

SponsorTerumo Medical Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-03-07

Results submitted2024-02-29

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