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Comparison of Glue with Microparticles in Prostatic Artery Embolization
Sponsor: Almaviva Sante
Summary
Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH). It has been practised since 2012 and numerous publications have proved not only its safety but also its efficacy. The principle of PAE is to occlude the prostatic arteries with an 'embolising agent', which will result in ischaemia and necrosis of part of the adenomatous tissue of the prostate. The reference embolisation agent is a suspension of calibrated trisacryl microparticles 300-500 microns in size. Recently, the use of glue has been retrospectively studied with acceptable efficacy and safety. In this context, where only the results of retrospective studies are available, it is necessary to initiate comparative prospective studies to assess the efficacy and safety of the glue compared with calibrated microparticles.
Official title: Comparison of the Efficacy and Safety of Glue with Calibrated Microparticles in Prostatic Artery Embolisation As a Treatment for Symptomatic Benign Prostatic Hyperplasia.
Key Details
Gender
MALE
Age Range
50 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2024-12-01
Completion Date
2027-05-31
Last Updated
2024-11-07
Healthy Volunteers
No
Conditions
Interventions
Embolisation with Magic Glue®
Magic Glue® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland
Embolisation with Embosphere®
Embosphere® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland
Locations (1)
Clinique de l'Alma
Paris, Paris, France