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

University Hospital Southampton NHS Foundation Trust

Status: Completed

Conditions: Embolization; Uterine Fibroid; Symptoms

Treatments: Device: Gel-Beads embolic material

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03072446

RHM RAD0041

Details and patient eligibility

About

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.

Full description

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Data from subjects treated with Gel-Bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the University Hospital Southampton.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

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

Gel-Beads arm

Experimental group

Description:

This group will undergo embolization of symptomatic uterine fibroids with Gel-Beads embolic agent

Treatment:

Device: Gel-Beads embolic material