跳至主要内容
临床试验/NCT03123835
NCT03123835Enrolling By Invitation不适用

Outcome Analysis of Endoluminal Therapies for Gastrointestinal Conditions Compared to Current Treatment Paradigms

University of California, Davis2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
500
试验地点
2
主要终点
Decrease in GERDDQ

研究概览

简要总结

Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.

详细描述

Over the last few years there have been numerous advances in the use of endoscopic equipment and related treatments in the identification and intervention of gastrointestinal diseases. Many of these treatments using flexible endoscopes have either complimented or replaced surgical approaches to these same benign and malignant disease processes with the potential of being the standard of care for many of these clinical conditions. The initial primary focus of this study will be the use of endoscopic myotomy for achalasia, endoscopic treatment of post bariatric weight gain, endoscopic gastro-gastric fistula treatments, and other endoluminal therapies for gastrointestinal and post-operative conditions. These treatments have been validated by prior surgery studies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult male and female patients 18-80 years of age
  • Meet the criteria for surgery of benign and/or malignant gastrointestinal pathology(s)
  • Gastrointestinal Reflux Disease
  • Achalasia
  • Barrett's Esophagus
  • Post Bariatric Surgery conditions
  • Other gastrointestinal and postsurgical disorders.

排除标准

  • Adults unable to consent
  • Individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees.

结局指标

主要结局

Decrease in GERDDQ

时间窗: 3-6 months

Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5)

次要结局

  • Decrease in Eckardt scoring(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验