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

Not Applicable

Completed

• Conditions: Uterine Fibroid; Symptoms; Embolization
• Interventions: Device: Gel-Beads embolic material

• Registration Number: NCT03072446
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

Brief Summary

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

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Data from subjects treated with Gel-Bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the University Hospital Southampton.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

• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-07
• Study Start: 2017-04-24
• Primary Completion: 2018-06-30
• Study Completion: 2018-09-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-08
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gel-Beads arm	Gel-Beads embolic material	This group will undergo embolization of symptomatic uterine fibroids with Gel-Beads embolic agent

Primary Outcome Measures

Name	Time	Method
Degree of Fibroid Tissue Infarction at 3 months	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.
Characterization of adverse events over 3 months	3 months	The primary safety endpoint is to characterize adverse events

Secondary Outcome Measures

Name	Time	Method
Change in uterine and dominant fibroid volumes	3 months	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).

Trial Locations

Locations (1)

Southampton University Hospital NHS Trust; 🇬🇧 Southampton, Hampshire, United Kingdom