Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation for Symptomatic Benign Prostatic Enlargement
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|ClinicalTrials.gov Identifier: NCT03109925|
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Device: DC Lumi Bead, BTG||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single group of patients undergoing prostate artery embolization with a new embolic which is radio-opaque and can give a better idea of embolization distribution (DC Lumi Beads by BTG)|
|Masking:||None (Open Label)|
|Masking Description:||No masking|
|Official Title:||Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation for Symptomatic Benign Prostatic Enlargement|
|Actual Study Start Date :||June 2, 2017|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Radio-opaque embolic arm
Patients will undergo intervention in the form of prostate artery embolization with the new radio-opaque embolic "Lumi-Bead" developed by BTG plc.
Device: DC Lumi Bead, BTG
Embolic agent which is radio-opaque
- Adverse event rate [ Time Frame: 12 months ]Rate of adverse events compared with currently available other embolic agents
- Scale of symptomatic improvement [ Time Frame: 12 months ]symptomatic improvement will be gauged used the internationally recognised IPSS questionnaire. Decrease in IPSS score in study participants will be compared against other embolic agents in the literature
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109925
|Contact: Drew Maclean||023 8120 firstname.lastname@example.org|
|Southampton General Hospital, University Hospital Southampton||Recruiting|
|Southampton, United Kingdom|
|Contact: Michelle Beveridge|
|Contact: Andrew Guy|
|Principal Investigator: Timothy Bryant|
|Principal Investigator:||Timothy Bryant||University of Hospital Southampton|