Bearing nsPVA Embolization for Uterine Fibroids

This study is looking at how well and how safely a medical device called Bearing nsPVA Embolization Particles works for women with symptomatic uterine fibroids. Uterine fibroids are non-cancerous growths in the uterus that can cause symptoms. The Bearing nsPVA particles are used to block blood flow to the fibroids. We want to see how safe this treatment is after 30 days and how effective it is after 6 months. You may be able to join if you are an adult woman (18 or older) with uterine fibroids that can be treated with embolization. The current recruitment status is unclear.

Study design
This is an observational study that plans to include 100 adult women. It will follow participants who receive the Bearing nsPVA Embolization Particles.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for 30 days and for effectiveness for 6 months after treatment.

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NCT06153667

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

Recruiting
Not specifiedAges 18+Observational
Merit Medical Systems, Inc.
~100 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Bearing nsPVA

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety
Measured over 30 days
+1 more outcome measured
Uterine Fibroid

NCT06153667

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Alfred Health

    Sydney, Australiastudy coordinator listed

    Recruiting

  • Royal Gwent Hospital (Aneurin Bevan UHB)

    Newport, United Kingdomstudy coordinator listed

    Recruiting

  • The Wesley Hospital

    Brisbane, Australiastudy coordinator listed

    Recruiting

  • Astra Vascular/Astra Vein Treatment Center

    Brooklyn, New Yorkno site contact published

    Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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

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).
  • Primary Safety30 days

    The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.

  • Primary Effectiveness6 months

    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.