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

Merit Medical Systems

Status: Enrolling

Conditions: Uterine Fibroid

Treatments: Device: Bearing nsPVA

Study type: Observational

Funder types: Industry

Identifiers

NCT06153667

UFE-P4-23-01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).