跳至主要内容
临床试验/NCT03948438
NCT03948438招募中不适用

Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2009年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Incidence of Adverse Events

研究概览

简要总结

Zenker's diverticulum (ZD) is a rare benign condition, due to an acquired sac-like outpouching of the mucosa and submucosa layers originating from the pharyngoesophageal junction. Endoscopic techniques like flexible endoscopic septum division (FESD) or per-oral endoscopic septotomy (POES), represent a minimally invasive alternative to surgery or to rigid endoscopic procedure to treat ZD. The goal of the research will be to evaluate the safety of the procedures and to measure Zenker-symptom severity in all patients treated by endoscopic procedures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • patients with symptomatic ZD treated by endoscopic procedures

排除标准

  • pregnancy and breastfeeding

结局指标

主要结局

Incidence of Adverse Events

时间窗: 24 hours after the procedure

Any complications as bleeding, perforation, others

次要结局

  • symptoms after the procedure(up to 5 years)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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