Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Technical and clinical success in endoscopic tissue apposition
研究概览
简要总结
This study is a prospective registry of patients undergoing endoscopic suturing and/or clip placement at our institution to assess the efficacy and safety of endoscopic tissue apposition.
1.1 Hypothesis: Endoscopic tissue apposition is efficacious and safe in the practice of gastrointestinal endoscopy.
1.2 Aims: To prospectively evaluate the efficacy and safety of Endoscopic Tissue Apposition in the practice of gastrointestinal endoscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients>18 years of age undergoing endoscopy for any of the following indications:
- •Indications for Tissue Apposition:
- •Closure of perforations
- •Closure of full thickness defects created during endoscopic full thickness resection
- •Closure of defects after endoscopic submucosal dissection and endoscopic mucosal resection
- •Closure of mucosotomy after Peroral Endoscopic Myotomy (POEM)
- •Stent fixation
- •Closure of fistulas
- •Natural Orifice Transluminal Endoscopic Surgery defect closures
- •Post-bariatric surgery gastrojejunal anastomosis and gastric pouch revision (transoral outlet repair)
- •Primary endoscopic sleeve gastroplasty
排除标准
- •Patients unable or unwilling to provide consent
- •Pregnant patients
- •Coagulation disorders (INR >1.8, platelet <50,000)
- •GI Bleeding
- •Hemodynamic instability
- •Enrollment in another device or drug study that may confound the results
结局指标
主要结局
Technical and clinical success in endoscopic tissue apposition
时间窗: From baseline to one year
Successful completion of endoscopic suturing/clipping and measured as clinical symptom improvement as well as objective evidence of resolution / improvement of underlying pathology / confirmed with radiologic contrast studies as needed..
Adverse Events
时间窗: From baseline to one year
Based on ASGE criteria
次要结局
未报告次要终点