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

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Merit Medical Systems, Inc.
Study ID
NCT06153667
Status
Recruiting
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Conditions

  • Uterine Fibroid

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bearing nsPVA — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 22, 2024
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

Primary Safety [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Astra Vascular/Astra Vein Treatment CenterBrooklynNew York11234-

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