Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
NCT ID: NCT06153667
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-08-22
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Bearing nsPVA
Bearing 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.
Eligibility Criteria
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Inclusion Criteria
* Subject has symptomatic uterine fibroid(s), suitable to embolization.
* Subject provides written informed consent.
Exclusion Criteria
* Subject has suspected pelvic inflammatory disease or any other pelvic infection.
* Subject has any malignancy of the pelvic region, (e.g., endometrial neoplasia).
18 Years
FEMALE
No
Sponsors
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Merit Medical Systems, Inc.
INDUSTRY
Responsible Party
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Locations
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The Alfred Health
Sydney, , Australia
Countries
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Central Contacts
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Other Identifiers
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UFE-P4-23-01
Identifier Type: -
Identifier Source: org_study_id
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