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

Primary Purpose

Uterine Fibroid, Embolization, Symptoms

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Gel-Beads embolic material
Sponsored by
University Hospital Southampton NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroid focused on measuring Uterine Fibroid, Embolization, symptoms, Gel-Beads

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Southampton University Hospital NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gel-Beads arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Characterization of adverse events over 3 months
The primary safety endpoint is to characterize adverse events

Secondary Outcome Measures

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).

Full Information

First Posted
March 2, 2017
Last Updated
May 8, 2019
Sponsor
University Hospital Southampton NHS Foundation Trust
Collaborators
Vascular Solutions LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03072446
Brief Title
Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.
Official Title
Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Southampton NHS Foundation Trust
Collaborators
Vascular Solutions LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroid, Embolization, Symptoms
Keywords
Uterine Fibroid, Embolization, symptoms, Gel-Beads

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gel-Beads arm
Arm Type
Experimental
Arm Description
This group will undergo embolization of symptomatic uterine fibroids with Gel-Beads embolic agent
Intervention Type
Device
Intervention Name(s)
Gel-Beads embolic material
Intervention Description
Patients will receive embolization of their uterine fibroids using Gel-Beads.
Primary Outcome Measure Information:
Title
Degree of Fibroid Tissue Infarction at 3 months
Description
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
Title
Characterization of adverse events over 3 months
Description
The primary safety endpoint is to characterize adverse events
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in uterine and dominant fibroid volumes
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel Hacking
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southampton University Hospital NHS Trust
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be available to other researchers.

Learn more about this trial

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

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