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.
Study Type
OBSERVATIONAL
Enrollment
100
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.
Astra Vascular/Astra Vein Treatment Center
Brooklyn, New York, United States
ACTIVE_NOT_RECRUITINGThe Wesley Hospital
Brisbane, Australia
RECRUITINGAlfred Health
Sydney, Australia
RECRUITINGPrimary Safety
The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.
Time frame: 30 days
Primary Effectiveness
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.
Time frame: 6 months
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Royal Gwent Hospital (Aneurin Bevan UHB)
Newport, United Kingdom
RECRUITING