Skip to main content
OpenTrials
Completed

NCT Number: NCT03072446

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uterine Fibroid Embolization Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Southampton University Hospital NHS Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

About this study

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Data from subjects treated with Gel-Bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the University Hospital Southampton.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gel-Beads embolic material

Device

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

Primary outcomes

  1. Degree of Fibroid Tissue Infarction at 3 months

    Time frame: 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.

  2. Characterization of adverse events over 3 months

    Time frame: 3 months

    The primary safety endpoint is to characterize adverse events

Secondary outcomes

  1. Change in uterine and dominant fibroid volumes

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Collaborators

  • Vascular Solutions LLC

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2017
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.