Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bearing nsPVA.
- Who it may be relevant to
- Registry conditions: Uterine Fibroid. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Primary Safety [Time frame: 30 days]
- Primary Effectiveness [Time frame: 6 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Australia · 2 centers
- The Wesley Hospital — Brisbane
- Alfred Health — Sydney
United States · 1 center
- Astra Vascular/Astra Vein Treatment Center — Brooklyn
United Kingdom · 1 center
- Royal Gwent Hospital (Aneurin Bevan UHB) — Newport
Identifiers
NCT: NCT06153667 · UFE-P4-23-01