Uterine FibroidBETTER-UAENCT06153667
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
An observational study of Uterine Fibroid, run by Merit Medical Systems, Inc. at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroid
- What is being tested?
- Bearing nsPVA
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 22 Aug 2024to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women ≥ 18 years with symptomatic uterine fibroid(s).
Who may be able to join
- Adult women ≥ 18 years old at the time of enrollment.
- Subject has symptomatic uterine fibroid(s), suitable to embolization.
- Subject provides written informed consent.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Vicky Brunk contact
4 sites in 3 countries
Australia2 sites, 2 recruiting
- Recruiting
The Wesley Hospital
Brisbane
Sepinoud Firouzmand, 0733719588, sepinoud.firouzmand@i-med.com.au
Nigel Mott, MD
- Recruiting
Alfred Health
Sydney
Adil Zia, 61414063499, a.zia@alfred.org.au
Warren Clements, MD
United States1 site
- Active, not recruiting
Astra Vascular/Astra Vein Treatment Center
Brooklyn, New York, 11234
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Gwent Hospital (Aneurin Bevan UHB)
Newport
Judith Omang, 01633 238084, Judith.Omang2@wales.nhs.uk
Nimit Goyal, MD
About this study
Official title: Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
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.
- Conditions
- Uterine Fibroid
- Being tested
- Bearing nsPVA
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bearing nsPVADevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety
The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.
Measured: 30 days
Primary Effectiveness
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start22 Aug 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153667
- Sponsor's protocol ID
- UFE-P4-23-01
- Acronym
- BETTER-UAE
- Status last verified
- Oct 2026
- First submitted
- 22 Nov 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
- ClinicalTrials.gov ID
- NCT06153667
- Acronym / sponsor ID
- BETTER-UAE / UFE-P4-23-01
- Conditions
- Uterine Fibroid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women ≥ 18 years with symptomatic uterine fibroid(s).
Key inclusion criteria (3 listed)
- Adult women ≥ 18 years old at the time of enrollment.
- Subject has symptomatic uterine fibroid(s), suitable to embolization.
- Subject provides written informed consent.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bearing nsPVABearing 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. | Device | – |
Primary outcome
Primary Safety
Time frame: 30 days
The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.
Primary Effectiveness
Time frame: 6 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vicky Brunk contact
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroid, run by Merit Medical Systems, Inc. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Molly Ryan (314-620-7095, molly.ryan@merit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.