Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AdventHealth
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Post procedural Reflux Rate
研究概览
简要总结
This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.
详细描述
This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.
This study will enroll 600 subjects over the next 4 to 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or older.
- •Scheduled to undergo POEM
排除标准
- •Any contraindication to performing endoscopy.
- •Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
研究组 & 干预措施
Esophageal POEM
Data will be collected for patients under going standard of care Esophageal POEM (E-POEM)
Gastric POEM
Data will be collected for patients under going standard of care Gastric POEM (G-POEM)
Zenker's POEM
Data will be collected for patients under going standard of care Zenker's diverticulum POEM (Z-POEM)
结局指标
主要结局
Post procedural Reflux Rate
时间窗: 12 months
Rate of Long-Term Clinical Success and Post-procedural Reflux Rate Among Patients with Esophageal Dysmotility Undergoing POEM
Long-Term Clinical Efficacy of Z-POEM for the management of Zenker's Diverticulum and Rate of Recurrence
时间窗: 12 months
The main outcome of this study is to evaluate rate of recurrence of symptoms after Z-POEM for Zenker's diverticulum. Recurrence is defined as a return of patient's symptoms (dysphagia, odynophagia) at the time of clinic follow-up.
Long-Term Clinical Efficacy of G-POEM for the management of medically refractory gastroparesis
时间窗: 12 months
The main outcome of the study is to evaluate the proportion of patients who have clinical response to GPOEM. Clinical response is measured by the validated symptom assessment tool (gastroparesis cardinal symptom index - GCSI). Patients with a decrease in GCSI by one or more point will be defined as having a clinical response.
Evaluate the efficacy of POEM for the management of gastrointestinal disease for esophageal motility.
时间窗: 12 months
The main outcome measure is to evaluate the long-term efficacy of POEM for esophageal motility disorders. Efficacy or clinical response is usually assessed using the Eckardt score. An Eckardt score of \< 3 is traditionally defined as treatment response following POEM.
次要结局
未报告次要终点