An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-06

Study Completion Date

2023-03-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Uterine Fibroid Arteriovenous Malformations Hypervascular Tumors Benign Prostatic Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment with HydroPearl via radial access

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

Treatment with HydroPearl via radial access

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No