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Clinical Trials in Australia / NCT06153667
Recruiting Observational

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

NCT06153667 · tracked via the Priya Life Science Australia tracker
Sponsor
Merit Medical Systems, Inc
Phase
Observational
Started
2024-08-22
Last updated
2026-10-07

Condition(s) studied

Uterine Fibroid

Investigational drug(s) / intervention(s)

Bearing nsPVA

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.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

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

Trial sites (4)

FacilityCityRegionStatus
Astra Vascular/Astra Vein Treatment Center Brooklyn New York Active Not Recruiting
The Wesley Hospital Brisbane Australia Recruiting
Alfred Health Sydney Australia Recruiting
Royal Gwent Hospital (Aneurin Bevan UHB) Newport United Kingdom Recruiting

More Merit Medical Systems, Inc. trials in Australia

GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION) Active, not recruiting
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06153667 on ClinicalTrials.gov ↗ ← All trials in Australia