Bearing nsPVA Embolization for Uterine Artery Embolization

Uterine Fibroid Clinical Trial

Official title:

Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06153667
• Other study ID #: UFE-P4-23-01
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: Merit Medical Systems, Inc.
• Contact: Irene Coughlin
• Phone: 6175435665
• Email: irene.coughlin[@]merit.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroid

Intervention

Device:
• Bearing nsPVA
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety	The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.	30 days
Primary	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