NCT05081752撤回不适用
Comparison of no Fixation vs. Stent Suturing vs. OTSC Stentfix in Preventing Esophageal Stent Migration in Esophageal Strictures
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
- Number of Participants who Experience Stent Migration
研究概览
简要总结
This study aims to assess the efficacy and rate of stent migration in standard of care esophageal stents that are not fixed, compared to those that are fixed with either standard of care OTSC stentfix or standard of care stent placement with suturing in both benign and malignant esophageal strictures.
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
Subjects 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
- 否
入选标准
- •The study population will include any adult (18 years +) who will undergo standard of care esophageal stent placement for benign or malignant esophageal strictures as either an inpatient or outpatient at NYULH.
- •The participant is able to consent to stent placements with fixation or without fixation and study procedures, verified by signature on the informed consent form.
- •Willing to comply with all study procedures and be available for the duration of the study.
- •English and Non-English speaking participants.
排除标准
- •Patients who have strictures treated with luman apposing stents.
结局指标
主要结局
Number of Participants who Experience Stent Migration
时间窗: Week 48
次要结局
- Total Procedural Time(120 minutes)
- Change in Score on Dysphagia Outcome and Severity Scale (DOSS)(Baseline, Week 48)
研究者
研究点 (1)
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