NCT06153667Recruiting
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
Merit Medical Systems, Inc.
Start Date
8/22/2024
Completion Date
12/1/2026
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 Criteria
Age Range: 18 years to No maximum
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
DEVICE
Bearing nsPVA
Conditions
Uterine Fibroid
Locations
Astra Vascular/Astra Vein Treatment Center
Brooklyn, New York 11234
United States
The Wesley Hospital
Brisbane,
Australia
Alfred Health
Sydney,
Australia
Royal Gwent Hospital (Aneurin Bevan UHB)
Newport,
United Kingdom