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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety | The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days. | 30 days |
| Primary Effectiveness | The primary effectiveness endpoint will be clinical success defined as ≥ 50% improvement in the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Symptom Severity subscale at 6 months as compared to baseline. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult women ≥ 18 years with symptomatic uterine fibroid(s).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Molly Ryan | Contact | 314-620-7095 | molly.ryan@merit.com | |
| Vicky Brunk | Contact | vicky.brunk@merit.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Astra Vascular/Astra Vein Treatment Center | Active, not recruiting | Brooklyn | New York | 11234 | United States | |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| The Wesley Hospital |
| Recruiting |
| Brisbane |
| Australia |
|
| Alfred Health | Recruiting | Sydney | Australia |
|
| Royal Gwent Hospital (Aneurin Bevan UHB) | Recruiting | Newport | United Kingdom |
|