Status:
RECRUITING
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
Lead Sponsor:
Merit Medical Systems, Inc.
Conditions:
Uterine Fibroid
Eligibility:
FEMALE
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 22 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06153667
Start Date
August 22 2024
End Date
October 1 2025
Last Update
November 22 2024
Active Locations (1)
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1
The Alfred Health
Sydney, Australia