Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
ConditionUterine Fibroid
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMerit Medical Systems, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult women ≥ 18 years old at the time of enrollment.
Subject has symptomatic uterine fibroid(s), suitable to embolization.
Subject provides written informed consent.
Disqualifiers
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 population
Adult women ≥ 18 years with symptomatic uterine fibroid(s).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bearing nsPVA
DeviceBearing 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Primary Safety
The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.
Time frame
30 days2
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.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov