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

Recruiting

• Conditions: Uterine Fibroid

• Registration Number: NCT06153667
• Lead Sponsor: Merit Medical Systems, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-11-22
• Study First Posted: 2023-12-01
• Study Start: 2024-08-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-04
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 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 Criteria

• 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness	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.
Primary Safety	30 days	The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.

Trial Locations

Locations (1)

The Alfred Health; 🇦🇺 Sydney, Australia