跳至主要内容
临床试验/NCT03626350
NCT03626350进行中(未招募)不适用

Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
250
试验地点
1
主要终点
Technical and clinical success in performing submucosal endoscopy

研究概览

简要总结

To test the idea that submucosal endoscopy is effective and safe for endoscopic myotomy, endoscopic submucosal dissection, and access for tissue acquisition and resection. Submucosal endoscopy is a recent innovative addition to gastrointestinal endoscopy. This involves endoscopic maneuvers in the gut wall, by dissection of the submucosal layer of GI tract, thereby allowing endoscopic myotomy (incision of the muscle), endoscopic access for tissue acquisition and therapy, and resection of precancerous and cancerous gastrointestinal tissue. This approach has been a dramatic game-changer for minimally invasive management of various gastrointestinal conditions such as Zenker's diverticulum, Achalasia, Spastic Esophageal Disorders, Gastroparesis, esophageal obstruction, Hirschsprung's Disease, and Gastrointestinal neoplasia.

The aim of the proposed study is to prospectively assess technical success, clinical success, and adverse events after submucosal endoscopy. Technical success will be defined as ability to successfully complete the submucosal endoscopic procedure. Clinical success will be defined as symptom relief and objective evaluation which will be assessed with radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology results routinely performed post-procedure for clinical care, as indicated. Adverse events will be recorded per published ASGE criteria.

A database/ registry of patients undergoing submucosal endoscopic procedures will be created to demonstrate this.

研究设计

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who will undergo submucosal endoscopy
  • Age >18 years

排除标准

  • Age <18 years
  • Coagulopathy (platelets less than 50, INR more than 1.8)

结局指标

主要结局

Technical and clinical success in performing submucosal endoscopy

时间窗: baseline to one year

Improvement in symptoms and objectively assessed by radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology.

Adverse Events

时间窗: baseline to one year

as defined by published ASGE criteria

次要结局

  • Submucosal endoscopy technique and device used(During procedure)
  • Procedure time(During procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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