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

NCT03072446 | Completed DMC FDA Device

• 1 other identifier: RHM RAD0041
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Fibroid; Embolization; Symptoms

Keywords

Uterine Fibroid; Embolization; symptoms; Gel-Beads

Outcome Measures

Primary Outcomes (2)

• 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

• Characterization of adverse events over 3 months

  The primary safety endpoint is to characterize adverse events

  3 months

Secondary Outcomes (1)

• Change in uterine and dominant fibroid volumes

  3 months

Study Arms (1)

Gel-Beads arm

EXPERIMENTAL

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

Device: Gel-Beads embolic material

Interventions

Gel-Beads embolic material DEVICE

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

Gel-Beads arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Vascular Solutions LLC: collaborator

Study Sites (1)

Southampton University Hospital NHS Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Nigel Hacking

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 7, 2017
• Study Start: April 24, 2017
• Primary Completion: June 30, 2018
• Study Completion: September 30, 2018
• Last Updated: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)