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

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.

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Key information

Conditions

Uterine Fibroid Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Wesley Hospital, Brisbane, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Bearing nsPVA

Device

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.

Primary outcomes

Primary Safety

Time frame: 30 days

The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.
Primary Effectiveness

Time frame: 6 months

The primary effectiveness endpoint will be clinical success defined as ≥ 50% improvement in the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Symptom Severity subscale at 6 months as compared to baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Molly Ryan

CONTACT

[email protected]

314-620-7095

Vicky Brunk

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Merit Medical Systems, Inc.

Industry

Registry information

Official study title

Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization

Acronym: BETTER-UAE

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Dec 1, 2023
Registry last updated: May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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