Evaluation of a Novel Endoscopic Treatment for Achalasia: Per-oral Endoscopic Esophagomyotomy (POEM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The success of the POEM procedure is measured by improved symptoms as compared to pre-op, including the ability to swallow with low incidence of GERD and significantly reduced resting LES pressure
研究概览
简要总结
This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of achalasia.
详细描述
This study will assess the feasibility and efficacy of a novel endoscopic procedure, Per-oral Endoscopic Esophagomyotomy (POEM)in treating patients with achalasia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •o Subjects with a manometric/radiologic diagnosis of primary achalasia; EGD shows no neoplasm
- •Ability to undergo general anesthesia
- •The subject is > 18 yrs.of age
- •Ability to give informed consent
排除标准
- •o Sigmoid achalasia
- •Contraindicated for EGD
- •Pregnancy
结局指标
主要结局
The success of the POEM procedure is measured by improved symptoms as compared to pre-op, including the ability to swallow with low incidence of GERD and significantly reduced resting LES pressure
时间窗: Within the first 3 months after surgery
Will assess the outcomes and efficacy of the endoscopic procedure, Per-oral Endoscopic Esophagomyotomy(POEM)in the treatment of achalasia. The patient will be assessed for improvement of their swallowing as assessed on the repeat time barium swallow and increase oral intake without nausea and vomiting.
次要结局
未报告次要终点