Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety and Efficacy of POEM Procedure
研究概览
简要总结
This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 patients.
详细描述
This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat or attempt to treat 20 patients. Patients for whom a POEM has been attempted but not completed (conversion to open or laparoscopic surgery, POEM surgery aborted and not re-attempted). Patients who proceed to study treatment will undergo ten years of follow-up as part of this study.
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
- 否
入选标准
- •Diagnosis of Achalasia
- •Age 16-80
- •ASA Class 1-3
排除标准
- •Pregnancy
- •Any prior surgical or endoscopic treatment for achalasia -- first eight subjects.
- •After eight subjects have been treated as part of this study, this exclusion criteria no longer applies
- •Patients who are taking immunosuppressive medications or are immunocompromised
- •Patients on anticoagulant medications or abnormal coagulation tests
- •Patients with severe medical comorbidities, in the judgment of the treating surgeon
结局指标
主要结局
Safety and Efficacy of POEM Procedure
时间窗: Intraoperative to one year follow-up
To assess adverse events related to POEM
Long-term patient-reported quality of life
时间窗: Baseline to one year follow-up
To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up.
次要结局
未报告次要终点
研究者
Kyle A Perry
Assistant Professor
Ohio State University