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 range18 Years

SexALL

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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.

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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