Therapeutic Endoscopic Ultrasound (EUS) Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- clinical success rates
研究概览
简要总结
The purpose of this prospective registry is to assess long-term data on efficacy, safety and clinical outcome of Therapeutic Endoscopic ultrasound (T-EUS) . The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures we are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.
详细描述
This study is a prospective, observational, medical chart review. There will be a retrospective chart review for patients who underwent endoscopic suturing procedures from October 2014 - May 2019. Those subjects will undergo no additional tests and procedures as part of this study.
In order to validate these procedures and broaden its use beyond tertiary centers, it is crucial to understand its efficacy and success rate. The objective of the study is to evaluate retrospectively and prospectively the efficacy and safety of T-EUS procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Any patient who has undergone clinically indicated and/or standard of care T-EUS procedures from October 2014 - May 2019
- •Any patient who will undergo clinically indicated and/or standard of care T-EUS procedures from June 2019 - June 2027
排除标准
- •Any patient who has not undergone endoscopic ultrasound would be excluded from the study.
- •Below 18 years of age
结局指标
主要结局
clinical success rates
时间窗: October 2014 - June 2022
Documentation of clinical success rates
Documentation of Safety
时间窗: October 2014 - June 2022
Number of subjects with Adverse Events; Type, frequency and intensity of adverse events
次要结局
未报告次要终点