Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Lift Efficacy
研究概览
简要总结
This is a study to determine how the viscosity (thickness) of an FDA approved gel affects the ease in which endoscopic mucosal resections (EMR) can be performed.
详细描述
This is a study to determine how the viscosity (thickness) of an FDA approved gel made by Cook medical affects the ease in which endoscopic mucosal resections (EMR) - a type of endoscopic surgery performed for localised cancer - can be performed when the gel is injected submucosally. The lifting characteristics of the gel will be assessed by height and diameter and ease with which the subsequent EMR dissection can be performed. These characteristics would be assessed on excised human stomachs and colon, which are harvested during routine sleeve gastrectomy surgeries or colectomies, in an ex-vivo manner.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pts undergoing sleeve gastrectomy
- •Pts undergoing colectomy
排除标准
- •Unable to give or understand consent
- •All of the excised tissue will be needed for diagnostic purposes
研究组 & 干预措施
Cook medical EMR Gel
Prospective study involving excised human stomachs and colon harvested from sleeve gastrectomies and colectomies performed for benign or malignant disease.
Different Cook submucosal injections of varying viscosities will be injected into different areas of the excised stomachs or colons.
Data collected will involve lifting characteristics and dissection adequacy of the varying viscosities of gel.
干预措施: Cook Medical EMR Gel (Drug)
结局指标
主要结局
Lift Efficacy
时间窗: 1 hour
Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection.
次要结局
- Dissection Adequacy(1 hour)
研究者
Antonios Likourezos
Research Administration Director
Maimonides Medical Center