UFE for Fibroids: Comparison of Gel-Bead to Common Embolic Agents
Research type
Research Study
Full title
Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.
IRAS ID
222138
Contact name
CN Hacking
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
RAD0041, Sponsor's Reference number
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
Uterine Fibroid Embolisation is a fully approved Intervention for managing women with symptomatic fibroids. The embolisation involves injecting tiny gelatin or plastic micro-particles directly into the uterine arteries on each side. The ideal embolic agent causes complete infarction of all fibroids without causing significant injury to the uterus itself.This study looks at a new form of Gelatin micro-particle and compares it with 5 commonly used particles.This particle is simply a new preparation of a well established embolic product. The patients will have the same standard of care as they would get outside the study. We would then look at the same parameters as are normally performed on these women as well as looking at Ovarian function which in theory might be even less affected by a temporary embolic agent. (Vs commonly used Plastic embolic agents which are permanent)
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
17/WM/0168
Date of REC Opinion
2 May 2017
REC opinion
Unfavourable Opinion