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

University Hospital Southampton NHS Foundation Trust11 enrolled

Overview

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 Data from subjects treated with Gel-Bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the University Hospital Southampton.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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uterine Fibroid Embolization Symptoms

Interventions

Gel-Beads embolic materialDEVICE

Patients will receive embolization of their uterine fibroids using Gel-Beads.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female, age 18 years or older 2. Symptomatic uterine fibroid(s) requiring treatment per the investigators assessment 3. Negative serum pregnancy test at the Baseline visit and practicing effective contraception during the study 4. Willing to provide written informed consent prior to initiation of study procedures 5. Willing to comply with the specified study assessments and follow-up requirements Exclusion Criteria: 1. Known hypersensitivity to porcine products or intravascular contrast material 2. Vascular anatomy or blood flow precluding correct catheter placement or embolic injection 3. Presence of collateral vessel pathways potentially endangering normal territories during embolization

Locations (1)

Southampton University Hospital NHS Trust

Southampton, Hampshire, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Characterization of adverse events over 3 months

The primary safety endpoint is to characterize adverse events

Time frame: 3 months

Secondary Outcomes

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).

Time frame: 3 months

Data from ClinicalTrials.gov

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