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
Qualifiers
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 design
Treatments tested in this trial
- Bearing nsPVA
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov