NCT03259191Unknown不适用
Department of Gastroenterology, Zhongda Hospital
Ruihua Shi1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement of symptoms
研究概览
简要总结
Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full sufficiency in literacy
- •Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks
- •Refractory gastroesophageal reflux disease
排除标准
- •Severe heart, lung, and cerebrovascular disease
- •Severe hematopoietic system disease
- •Abnormal blood coagulation function
- •Oropharyngeal abnormalities
- •Severe spine malformation
- •In pregnancy and lactation at present, or plan to become pregnant within 2 years
- •Severe inflammation or huge ulcers in stomach
- •Mental and psychological disorde
研究组 & 干预措施
completely circumferential ARMS
Other
干预措施: anti-reflux mucosectomy (Procedure)
semi-circumferential ARMS
Other
干预措施: anti-reflux mucosectomy (Procedure)
结局指标
主要结局
Improvement of symptoms
时间窗: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Improvement of all the symptoms related with RGERD.
次要结局
- Complications of ARMS(1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months)
研究者
Ruihua Shi
MD, PhD, Postdoctoral Mentor, Chief Physician
Zhongda Hospital
研究点 (1)
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