Prospective Randomized Trial to Compare the Adenoma Detection Rate of G-EYE™ Colonoscopy With Standard Colonoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 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 (ADR) of the G-EYE™ colonoscopy with that of standard colonoscopy.
详细描述
This is a single-center, two-arm , randomized, open-label study intended to compare the detection rate obtained by performing G-EYE™ colonoscopy vs. the detection rate obtained by performing standard colonoscopy.
The study will enroll 350 subjects. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll in this randomized clinical study if the candidate meets the study inclusion and exclusion criteria.
Subjects will sign an informed consent form and undergo randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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, for diagnostic evaluation 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 that have not stopped using anticoagulants as required by the guidelines of the medical center;
- •Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
- •Any patient condition deemed too risky for the study by the investigator
- •Previous colonic surgery (except for appendectomy)
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: Approximately following 14 days (histology results)
次要结局
- Polyp and adenoma detection(Up to 14 days (Histology results))
- Procedure times(At time of procedure)
- Safety (number of patients with adverse events)(48-72 hours)