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