NCT01199679终止不适用
Evaluation of Distal Esophageal and Cardia Rubber Band Ligation and Mucosectomy in the Treatment of Subjects With Gastroesophageal Reflux Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Reduction of reflux symptoms measured by GERD HRQL
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of two separate procedures to treat gastroesophageal reflux disease (GERD) also known as heartburn. The two therapies are: 1) a banding procedure alone using the Cook® 6 Shooter™ Saeed Multi-Band Ligator or 2) a banding/shaving procedure called Endoscopic Mucosal Resection (EMR) using the Cook® Duette™ Multi-Band Mucosectomy device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Subject is 18 years of age or older.
- •Typical symptoms of heartburn and/or regurgitation requiring daily PPI therapy.
- •Subject agrees to participate and signs consent form.
排除标准
- •Patient is pregnant.
- •Patient has a hiatal hernia greater than 2cm.
- •Presence of persistent daily solid food dysphagia, unplanned weight loss over ten pounds, esophageal bleeding, or vomiting more than once per week).
- •Active medical condition that would preclude the subject from finishing this study.
- •BMI > 39.
结局指标
主要结局
Reduction of reflux symptoms measured by GERD HRQL
时间窗: 6 months
HRQL = Health Related Quality of Life Questionnaire
次要结局
- Reduction in total esophageal acid exposure measured by 48 hour pH monitoring(6 months)
研究者
研究点 (2)
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