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

Uterine Fibroid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072446
• Other study ID #: RHM RAD0041
• Status: Completed
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: May 2019
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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Data from subjects treated with Gel-Bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the University Hospital Southampton.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolization
• Leiomyoma
• Symptoms
• Uterine Fibroid

Intervention

Device:
• Gel-Beads embolic material
Patients will receive embolization of their uterine fibroids using Gel-Beads.

Locations

Country	Name	City	State
United Kingdom	Southampton University Hospital NHS Trust	Southampton	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust	Vascular Solutions, Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Characterization of adverse events over 3 months	The primary safety endpoint is to characterize adverse events	3 months
Secondary	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