Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia
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|ClinicalTrials.gov Identifier: NCT02822924|
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostate Hyperplasia||Procedure: Prostate artery embolization (PAE)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2020|
Prostate artery embolization treatment
Prostatic artery embolization (PAE) as a new treatment technology is a potentially promising, minimally invasive alternative procedure for BPH, which has been shown to be safe and effective in both animal models and clinical trials.
Procedure: Prostate artery embolization (PAE)
Right femoral arterial puncture is performed under local anesthesia. The blood supply to the prostate is mapped by angiography of the iliac vessels and the prostate arteries. Microcatheters are used for super-selective catheterization of the right and left inferior vesicle arteries. Embolization is performed with a microcatheter to deliver microspheres of 300 micron diameter. The microsphere mixture is slowly injected under fluoroscopic guidance. The endpoint of embolization is flow stasis in the prostatic vessels with prostatic gland opacification, without reflux of the mixture to undesired arteries.
- successful procedure [ Time Frame: within 1 hour after PAE procedure ]Procedure success defined as technically successful selective prostatic arterial catheterization and embolization
- Incidence of procedure related complication [ Time Frame: 6-8 hours after treatment until 1 month time ]Complication after treatment procedure will be recorded. Major adverse events, which included ischemic, infectious, or puncture site complications, pain will be recorded and evaluated. Further imaging or laboratory studies are conducted when a complication was suspected.
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): NCT02822924
|Contact: Carmen Wong||(852) 3505 firstname.lastname@example.org|
|Contact: Pui Man Chong||(852) 3505 email@example.com|
|Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Carmen Wong (852) 3505 3210 firstname.lastname@example.org|
|Contact: Sally Lee (852) 3505 2046 email@example.com|
|Principal Investigator:||Simon Yu, Profesor||Chinese University of Hong Kong|