Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
Merit Medical Systems, Inc.
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
- Age range
- 18+ years
- Sex
- Female
- 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).
Interventions
- DeviceBearing 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.
Locations (4)
- Astra Vascular/Astra Vein Treatment CenterBrooklyn, New York
- The Wesley HospitalBrisbane
- Alfred HealthSydney
- Royal Gwent Hospital (Aneurin Bevan UHB)Newport