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

NCT03072446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-05-09

No results posted yet for this study

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

Interventions

DEVICE

Gel-Beads embolic material

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

Sponsors & Collaborators

  • Vascular Solutions LLC

    collaborator INDUSTRY

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Nigel Hacking · University Hospital Southampton NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2018-06-30
Completion
2018-09-30
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03072446 on ClinicalTrials.gov