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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06153667
Other study ID # UFE-P4-23-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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