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NCT06153667 | RECRUITING | Uterine Fibroid

Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
Sponsor:

Merit Medical Systems, Inc.

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 will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.

Condition or disease

Uterine Fibroid

Intervention/treatment

Bearing nsPVA

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
Actual Study Start Date : 2024-08-22
Estimated Primary Completion Date : 2025-04
Estimated Study Completion Date : 2025-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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).
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)

Location Details

NCT06153667

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Australia,

The Alfred Health

Sydney, Australia,