G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate - Randomized Tandem Study With Different Endoscopist
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- G-EYE™ colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same.
研究概览
简要总结
The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition colonoscopy with that of standard high definition colonoscopy.
详细描述
Single Center, two-arm, randomized , open-label study with different and blinded endoscopists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over 50 years old
- •Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection).
- •The patient must understand and provide written consent for the procedure.
排除标准
- •Subjects with inflammatory bowel disease;
- •Subjects with a personal history of polyposis syndrome;
- •Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- •Subjects with diverticulitis or toxic megacolon;
- •Subjects with a history of radiation therapy to abdomen or pelvis;
- •Pregnant or lactating female subjects;
- •Subjects who are currently enrolled in another clinical investigation.
- •Subjects with current oral or parenteral use of anticoagulants
- •Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
研究组 & 干预措施
Group A
Subjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy
干预措施: Standard Colonoscopy (Procedure)
Group A
Subjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy
干预措施: G-EYE(TM) Colonoscopy (Procedure)
Group B
Subject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy
干预措施: Standard Colonoscopy (Procedure)
Group B
Subject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy
干预措施: G-EYE(TM) Colonoscopy (Procedure)
结局指标
主要结局
G-EYE™ colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same.
时间窗: estimated 14 days (following histology results)
次要结局
- polyp and adenoma detection, procedure times and safety(24-72 hours post procedure)