Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Data from subjects treated with Gel-Bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the University Hospital Southampton.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.

Official Title
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Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.

Conditions
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Uterine Fibroid, Embolization, Symptoms

Intervention / Treatment
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* Device: Gel-Beads embolic material


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, age 18 years or older Symptomatic uterine fibroid(s) requiring treatment per the investigators assessment Negative serum pregnancy test at the Baseline visit and practicing effective contraception during the study Willing to provide written informed consent prior to initiation of study procedures Willing to comply with the specified study assessments and follow-up requirements Exclusion Criteria: Known hypersensitivity to porcine products or intravascular contrast material Vascular anatomy or blood flow precluding correct catheter placement or embolic injection Presence of collateral vessel pathways potentially endangering normal territories during embolization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gel-Beads arm<br>This group will undergo embolization of symptomatic uterine fibroids with Gel-Beads embolic agent | Device: Gel-Beads embolic material<br>* Patients will receive embolization of their uterine fibroids using Gel-Beads.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine Fibroid, Embolization, symptoms, Gel-Beads