NCT03109925

Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation for Symptomatic Benign Prostatic Enlargement

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: University Hospital Southampton NHS Foundation Trust · Academic / Other
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution.

Detailed description

This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution. It would also give us answers to: * How does embolic efficacy compare to current available embolic agents? * Does enhancement on rotational CT correlate with embolic distribution? * How does embolic distribution compare with tissue infarction? * Does the density of embolic packing correlate with degree of infarction and volume loss? * How predictable is superselective target embolisation? * Does embolic distribution vary with anatomy and gland size? * Does embolic distribution tally with glandular enhancement/ transitional zone vascularity? * If visible, what is the effect and significance of non target embolisation? This is a cohort study aiming to recruit 22 patients to power a non-inferiority assessment comparing the novel embolic agent against current available embolics. Data will be added to our on going local registry of patients who have undergone this procedure . This will provide information about how safe and effective it is for patients and how it compares to the other established embolic agents such as polyvinyl alcohol (PVA) and other spherical agents such as Embospheres and Embozenes.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	DC Lumi Bead, BTG	Embolic agent which is radio-opaque

Timeline

• Start date: 2017-06-02
• Primary completion: 2021-06-29
• Completion: 2021-06-29
• First posted: 2017-04-12
• Last updated: 2020-10-22

Locations

1 site across 1 country: United Kingdom