A Randomized Study of Biologic Scaffolds And Esophageal Healing Following Endoscopic Resection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Completeness of EMR Site Healing at Follow up Endoscopy
研究概览
简要总结
This study is being done to test the usefulness of extracellular matrix (ECM) a thin sheet placed over the site after endoscopic mucosal resection to promote healing of the esophagus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Able to provide consent
- •Scheduled for standard of care endoscopy that may require initial EMR evaluation of esophageal lesions
- •Histological evidence of intestinal metaplasia with dysplasia or intramucosal carcinoma
排除标准
- •Pregnant women
- •Prior esophageal EMR or ESD in the same region
- •Anyone unable to provide informed consent
- •Medical co-morbidities precluding EGD evaluation
- •History of chemoradiotherapy to the neck/esophagus
- •Unable to stop anticoagulation therapy (non-steroid anti-inflammatory medications are permissible)
研究组 & 干预措施
Endoscopic submucosal resection with Extracelluar Matrix
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.
干预措施: Acell MatriStem® Surgical Matrix (Device)
Endoscopic submucosal resection standard of care
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.
结局指标
主要结局
Completeness of EMR Site Healing at Follow up Endoscopy
时间窗: approximately 3-4 months post EMR
Number of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy.
次要结局
- Presence of Stricture Formation at Follow up Endoscopy(approximately 3-4 months post EMR)
研究者
Kenneth K. Wang
Pricipal Investigator
Mayo Clinic