RecruitingNCT06153667

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

Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization

Sponsor

Merit Medical Systems, Inc.

Enrollment

100 participants

Start Date

Aug 22, 2024

Study Type

OBSERVATIONAL

Conditions

Uterine Fibroid

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (BETTER-UAE) is comparing two types of tiny beads (embolic agents) used in a minimally invasive procedure called uterine artery embolization (UAE). UAE is a non-surgical treatment for uterine fibroids (non-cancerous growths in the uterus) that blocks blood flow to the fibroids to shrink them and relieve symptoms like heavy bleeding and pelvic pain. **You may be eligible if...** - You are a woman aged 18 or older - You have symptomatic uterine fibroids that have been determined suitable for embolization - You are willing to provide written informed consent **You may NOT be eligible if...** - You are pregnant - You have a suspected pelvic inflammatory infection - You have any cancer or malignancy in the pelvic area (such as endometrial cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.