jRCTs052240042招募中不适用
Phase II study to evaluate the safety and efficacy of esophageal stenting for benign esophageal perforation and fistula
未提供0 个研究点目标入组 15 人开始时间: 2024年11月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria are included
- •Benign esophageal perforation or fistula is confirmed by endoscopy.
- •Difficult to close with existing therapies.
- •No obvious abscess in the mediastinum or abdominal cavity.
- •The patient is at least 18 years of age at the time consent is obtained.
- •Written consent to participate in the study has been obtained from the patient.
排除标准
- •Patients with any one of the following conditions are excluded
- •Systolic blood pressure less than 90 mmHg.
- •Pregnant women or patients who may be pregnant.
- •Other patients deemed inappropriate by the principal investigator or sub-investigator.
结局指标
主要结局
-
Clinical success rate
次要结局
未报告次要终点
研究者
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