NCT06483503进行中（未招募）不适用
A Prospective Cohort Study Evaluating a Novel Colonoscope With a 230-degree Extra-wide Field of View Optics (EFOV)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cecal Intubation Rate
研究概览
简要总结
The goal of this observation study is to learn about the feasibility of a new colonoscope which provides the physician an extra-wide field of view during a screening colonoscopy. The main question this study aims to answer is can this new type of colonoscope locate polyps during clinical use in patients.
Patients will undergo a routine colonoscopy for colorectal cancer or polyp surveillance and have one follow-up phone call up to 2 weeks of the colonoscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Screening for colorectal cancer at the age greater than or equal to 50 years, or evaluation of a positive stool test (i-FOBT) or polyp surveillance.
- •Signed informed consent.
排除标准
- •ASA classification ≥
- •Age <18 years.
- •Known or suspicion of inflammatory bowel disease.
- •Known polyp(s) for polypectomy.
- •High risk for colorectal cancer, history of extensive polyposis, patients with known genetic disease.
- •Prior colorectal surgery.
- •Vulnerable subjects or subjects unable to follow the procedures of the investigation, e.g., due to language problems.
- •Unable or unwilling to undergo bowel cleansing for colonoscopy.
- •Female patients who are pregnant or nursing.
- •Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
结局指标
主要结局
Cecal Intubation Rate
时间窗: Day 1
The proportion of procedures in which the cecum was reached.
次要结局
- Mean number of polyps per coloscopy and its detection rate(Day 1)
- Mean number of adenomas and its detection rate(Day 14)
- Procedure Time(Day 1)
- Ileum Intubation Rate(Day 1)
- Mean number of sessile serrate lesions and its detection rate(Day 14)
- Therapeutic Intervention Success Rate(Day 1)
- Patient Satisfaction Survey(Day 14)
研究者
研究点 (1)
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