Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)

NCT ID: NCT06153667

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-22

Study Completion Date

2025-10-31

Brief Summary

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This is a prospective, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. Data collection will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.

Detailed Description

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Conditions

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Uterine Fibroid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Bearing nsPVA

Bearing nsPVA Embolization Particles are irregularly-shaped, biocompatible, hydrophilic, nonresorbable particles produced from polyvinyl alcohol. These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon selective placement through a variety of catheters. Bearing nsPVA Embolization Particles are used for the embolization of symptomatic (leiomyoma uteri) uterine fibroids.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult women ≥ 18 years old at the time of enrollment.
* Subject has symptomatic uterine fibroid(s), suitable to embolization.
* Subject provides written informed consent.

Exclusion Criteria

* Subject is pregnant.
* Subject has suspected pelvic inflammatory disease or any other pelvic infection.
* Subject has any malignancy of the pelvic region, (e.g., endometrial neoplasia).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merit Medical Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Alfred Health

Sydney, , Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Irene Coughlin

Role: CONTACT

6175435665

Vicky Brunk

Role: CONTACT

Other Identifiers

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UFE-P4-23-01

Identifier Type: -

Identifier Source: org_study_id

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