Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation

Status Recruiting

Clinical Trial Summary

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03109925
Study type	Interventional
Source	University Hospital Southampton NHS Foundation Trust
Contact	Drew Maclean
Phone	023 8120 8002
Email	drew.maclean@uhs.nhs.uk
Status	Recruiting
Phase	Phase 2
Start date	June 2, 2017
Completion date	June 29, 2021

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms