Prostate Artery Embolization (PAE) with the SeQure microcatheter
Research type
Research Study
Full title
Use of a novel reflux control microcatheter (SEQure, Guerbert, Paris, France) in prostate artery embolisation (PAE) for symptomatic benign prostatic enlargement
IRAS ID
280309
Contact name
Sharon Davies-Dear
Contact email
Sponsor organisation
University Hospital Southampton
Duration of Study in the UK
3 years, 0 months, days
Research summary
Prostate Artery Embolization (PAE) is a minimally invasive procedure which aims to provide another option to patients with Benign Prostatic Hypertrophy (BPH). BPH is a common and debilitating condition which can significantly impact on quality of life.
The procedure is performed by an Interventional Radiologist who uses image-quided techniques to steer a 'microcatheter' (tiny tube) to the prostate and block its blood vessels (with tiny particles) to make it shrink and relieve the symptoms. A wealth of data has shown this is almost as effective as surgery and is now recommended by NICE as a recognised treatment for BPH.
One potential and rare complication of PAE is if the tiny particles are steered into vessels which do not supply the prostate, such as the rectum or bladder, damaging these organs. This is known as 'non-target embolization'. Limiting non-target embolization is one of the main aims of the procedure.
The medical device industry have responded to these concerns and developed a CE-marked microcatheter (Sequre catheter, Guebert, Paris France) approved for use in Interventional Radiology procedures and proven to limit 'non-target embolization' in procedures similar to PAE. The Sequre microcatheter has not been studied in PAE. We therefore wanted to assess its safety and clinical efficacy in this specfic procedure through a pilot study device registry. This is important to prove it is as effective as other microcatheters and to show if it potentially has a reduction in non-target embolization. Patients will recieve the same standard of care as all other PAE patients, but they will undergo PAE with the SEqure catheter and have data collected prospectively over 12 months of follow-up (this is our usual follow-up period for all patients).
REC name
Wales REC 6
REC reference
20/WA/0318
Date of REC Opinion
13 Jan 2021
REC opinion
Further Information Favourable Opinion