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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Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
At a glance
Conditions
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.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- 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.