Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.
NCT ID: NCT03072446
Last Updated: 2019-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2017-04-24
2018-09-30
Brief Summary
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Detailed Description
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Data from subjects treated with Gel-Bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the University Hospital Southampton.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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gel-Beads arm
This group will undergo embolization of symptomatic uterine fibroids with Gel-Beads embolic agent
Gel-Beads embolic material
Patients will receive embolization of their uterine fibroids using Gel-Beads.
Interventions
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Gel-Beads embolic material
Patients will receive embolization of their uterine fibroids using Gel-Beads.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Vascular Solutions LLC
INDUSTRY
University Hospital Southampton NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Nigel Hacking
Role: PRINCIPAL_INVESTIGATOR
University Hospital Southampton NHS Foundation Trust
Locations
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Southampton University Hospital NHS Trust
Southampton, Hampshire, United Kingdom
Countries
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Other Identifiers
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RHM RAD0041
Identifier Type: -
Identifier Source: org_study_id
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