NCT01584635已完成不适用
Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less invasive treatment for Achalasia has been developed.
The purpose of this study is to decide the role this less invasive treatment (Peroral Endoscopic Myotomy) has in the treatment of patient's 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
- 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
- •Patients between the ages of 18 and 80 with achalasia diagnosed by a combination of compatible symptoms, barium esophagography and high resolution manometry.
排除标准
- •Patients who are poor surgical risks, have had previous treatment for achalasia or esophageal or gastric surgery, have an epiphrenic diverticulum or are unwilling to be followed in the protocol.
- •Female patients are eligible if they are NOT pregnant or lactating AND ne of the following criteria is met:
- •The patient is surgically sterile (by means of hysterectomy/bilateral tubal ligation)
- •The patient is at least one year postmenopausal (no menses for 12 months).
- •The patient is using a highly effective method of contraception, if childbearing potential, AND has a negative urine human chorionic gonadotropin beta subunit (ß HCG) pregnancy test result during Screening, and prior to trial drug administration.
- •Highly effective methods of birth control are defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
- •Withdrawal, single- or double barrier methods (including condoms) and rhythm methods are NOT ACCEPTABLE methods of contraception for the purposes of this clinical trial due to the high incidence of contraceptive failures with these methods.
- •Vulnerable populations, such as those with diminished mental acuity, will be excluded.
结局指标
主要结局
Number of participants with adverse events
时间窗: 5 years post surgery
Patients in this study, undergoing the Peroral Endoscopic Myotomy treatment for Achalasia, will be accessed at 1 month, 6 months, at 1-2-3-4 and year 5 post surgery. We will measure outcomes by number of adverse events, Eckardt symptom score, barium esophagram, and manometry studies.
次要结局
- Eckardt symptom score(5 years)
研究者
David A. Katzka
Principal Investigator
Mayo Clinic
研究点 (2)
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