跳至主要内容
临床试验/NCT05395299
NCT05395299已完成不适用

Feasibility of Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer ) in Symptomatic Patients with Benign Prostatic Hyperplasia: Monocentric Pilot Study

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
The main objective is to study the feasibility of prostate embolization with SQUID

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The main objective is to study the feasibility of prostate embolization with SQUID

时间窗: day 0

squid injection success in the prostate assessed by a scanner

次要结局

  • Description of the causes of technical embolization failures(day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验