NCT06015607招募中不适用
Testing of GripTract-GI Endoscopic Tissue Manipulator for Use During Complex Endoscopic Polypectomies in the Colon
Actuated Medical, Inc.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年6月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to compare the safety and effectiveness of the GripTract GI Endoscopic Tissue Manipulator to the current standard of care for complex polypectomies in adults. The main questions it aims to answer are:
- How does the number and severity of Device-Attributable Adverse Events compare to the current standard of care?
- How is the procedure time affected?
- Is the ability to resect the tissue en bloc affected?
- What is the user feedback on the device performance?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for endoscopic removal of suspected adenomatous benign polyps(s)
- •Patients capable of giving informed consent English and lacking cognitive impairment
- •No medical contraindication to endoscopic mucosal resection or endoscopic submucosal dissection
排除标准
- •Patients less than 21 years of age
- •Any contraindication to colonoscopy with due to subject's colon anatomy (i.e., structure)
- •History of open or laparoscopic colorectal surgery
- •History of Inflammatory Bowel Disease
- •Patients requiring multiple polyp removals
研究者
研究点 (1)
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