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| Name | Class |
|---|---|
| Vascular Solutions LLC | INDUSTRY |
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The purpose of this post-market study is to evaluate UFE agents for the treatment of symptomatic uterine fibroids, using Gel-Bead compared to four other commonly used embolic agents.
This single-center, prospective study will be conducted at one site in the United Kingdom. Up to 30 subjects will be enrolled and treated with Gel-Bead. Prospectively. Enrolled Gel-Bead subjects will be followed at 1-month and 3-months post-procedure.
Data from subjects treated with Gel-Bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the University Hospital Southampton. This study evaluated 20 subjects in five different treatment groups for the treatment of symptomatic uterine fibroids. The five treatment groups include gelatin foam slurry, Embospheres, polyvinyl alcohol (PVA), Bead Block and Embozenes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gel-Beads arm | Experimental | This group will undergo embolization of symptomatic uterine fibroids with Gel-Beads embolic agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gel-Beads embolic material | Device | Patients will receive embolization of their uterine fibroids using Gel-Beads. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Fibroid Tissue Infarction at 3 months | The primary endpoint is the degree of fibroid tissue infarction at 3 months post-procedure. Results for the total fibroid load and the dominant fibroid will be categorized as either 100% (Group A) ≥ 90-99% (Group B) or <90% (Group C) infarcted. The degree of infarction will be visually estimated by the investigator. | 3 months |
| Characterization of adverse events over 3 months | The primary safety endpoint is to characterize adverse events | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in uterine and dominant fibroid volumes | Changes in uterine and dominant fibroid volumes between pre-procedure and Month 3 based on CE-MRI. The absolute dimensions of the uterus will be measured and the approximate uterine volumes will be calculated using the formula for a prolate ellipse (length X width X depth X 0.5233). | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nigel Hacking | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southampton University Hospital NHS Trust | Southampton | Hampshire | SO16 6YD | United Kingdom |
No individual participant data will be available to other researchers.
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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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