跳至主要内容
临床试验/NCT04936425
NCT04936425撤回不适用

Comparison of Stent Suturing Versus OTSC Stentfix in Preventing Esophageal Stent Migration in Non-Stricture Esophageal Lesions

NYU Langone Health1 个研究点 分布在 1 个国家开始时间: 2023年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Average rate of stent migration

研究概览

简要总结

The purpose of this study is to investigate whether OTSC stentfix is a feasible, safe, and efficient device that can be used for esophageal stent fixation (to prevent stent migration) in patients with benign, non-stricture esophageal lesions, including leaks, perforation, and fistulae. Currently, self-expandable metal stents (SEMS) have a risk of migration which can lead to adverse events such as bleeding and perforation. There has been clinical experience demonstrating that stent suturing can prevent stent migration. However, stent suturing can significantly increase endoscopic procedural time. The use of OTSC stentfix for stent fixation is promising as it is likely less time-consuming and less technically difficult, with likely a similar rate of fixation and migration. This non-inferiority study aims to investigate how OTSC stentfix functions as compared to stent suturing. If OTSC stentfix is at least comparable to stent suturing, it can reduce endoscopy procedural times, minimize peri-endoscopic risks, and minimize adverse events related to stent migration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Patients will be blinded as to which study arm they are in, in order to avoid any bias they may have.

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

  • All adults (18+ years)
  • Have benign, non-stricture esophageal lesions (i.e. fistulae, perforation, leaks) warranting esophageal stent placement as an inpatient or outpatient
  • Ability to consent to stent fixation.

排除标准

  • < 18 years old

结局指标

主要结局

Average rate of stent migration

时间窗: 48 weeks

次要结局

  • Procedural time needed for stent fixation(120 minutes)
  • Duration of time until stent migration for stents that fail fixation(48 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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