CHU de Nice
Nice, France, 06000
NCT Number: NCT05395299
The aim of this pilot study is to analyze the feasibility of prostatic embolization for the treatment of symptomatic benign prostatic hypertrophy with a non adhesive liquid embolic agent (Squid)
Looking for future studies?
Notify Me18 year–80 year
Male
Interventional
Not applicable
Nice, France, 06000
Microparticle prostatic embolization is an effective technique in the short and medium term in the treatment of symptoms related to benign prostatic hyperplasia. If this technique allows an improvement of the patients' symptoms, and fewer operative complications than urological interventions, on the other hand, the injection of arterial particles has several disadvantages: a random long-term durability mainly due to a revascularization of the embolized territories ; inferiority compared to urological treatments in terms of reduction of prostate volume and improvement of postoperative urodynamic tests; poor visualization of the embolization material, and a risk of injection of the particles into an artery supplying a non-target organ. Ethylene vinyl alcohol copolymer is a liquid embolism used for the endovascular treatment of cerebral arteriovenous malformations since 2005 and in specific extracerebral applications due to its advantageous physical properties (its viscous nature, its slow polymerization, its definitive and very distal occlusion, and its high fluoroscopic visibility). These properties would allow in prostatic embolization: to obtain better control during the injection and therefore to improve the safety of the embolization; to reduce the risk of recurrence; and to achieve a more intense prostatic ischemia and therefore to obtain a greater reduction in prostatic volume, and a better improvement in urodynamic tests. The aim of this pilot study is to analyze the feasibility of injecting this liquid embolic agent during the endovascular treatment of symptomatic benign prostatic hypertrophy. If this preliminary study is positive, a randomized phase III study could be undertaken to judge the results and the place of this technique in the treatment of symptoms related to benign prostatic hyperplasia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patient with prostate cancer or suspected of having prostate cancer
Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer )
Time frame: day 0
squid injection success in the prostate assessed by a scanner
Time frame: day 0
Injection into the 2 prostate lobes
Centre Hospitalier Universitaire de Nice
Other
Feasibility of Prostatic Arterial Embolization With SQUID (Ethylene Vinyl Alcohol Copolymer ) in Symptomatic Patients With Benign Prostatic Hyperplasia: Monocentric Pilot Study
Acronym: SQUID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06849089
Genital Diseases, Genital Diseases, Male
Istanbul, Pendik, Turkey (Türkiye)
View Trial DetailsNCT06620614
Genital Diseases, Genital Diseases, Male
Kathmandu, Nepal
View Trial DetailsNCT03653117
Genital Diseases, Genital Diseases, Male
Amsterdam, North Holland, Netherlands
View Trial DetailsNCT02943070
Adenoma, Prostatic, Benign Prostatic Hyperplasia
Brno, Czechia
View Trial Details