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

NCT06153667 | Recruiting

• 1 other identifier: UFE-P4-23-01
• Study Type: observational
• Target: 100
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Uterine Fibroid

Outcome Measures

Primary Outcomes (2)

• Primary Safety

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

  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.

  6 months

Interventions

Bearing nsPVA DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women ≥ 18 years with symptomatic uterine fibroid(s).

You may qualify if:

• Adult women ≥ 18 years old at the time of enrollment.
• Subject has symptomatic uterine fibroid(s), suitable to embolization.
• Subject provides written informed consent.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (4)

Astra Vascular/Astra Vein Treatment Center

Brooklyn, New York, 11234, United States

RECRUITING

The Wesley Hospital

Brisbane, Australia

RECRUITING

Alfred Health

Sydney, Australia

RECRUITING

Royal Gwent Hospital (Aneurin Bevan UHB)

Newport, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Molly Ryan

CONTACT

314-620-7095; molly.ryan@merit.com

Vicky Brunk

CONTACT

vicky.brunk@merit.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: August 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); GB (1); AU (2)