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Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
RECRUITINGSponsored by Merit Medical Systems, Inc.
Actively Recruiting
SponsorMerit Medical Systems, Inc.
Started2024-08-22
Est. completion2025-04
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06153667
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.
Eligibility
Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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).
Conditions2
CancerUterine Fibroid
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Actively Recruiting
SponsorMerit Medical Systems, Inc.
Started2024-08-22
Est. completion2025-04
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06153667