A 4-arm Randomized Controlled Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,262
- 试验地点
- 2
- 主要终点
- Adenomas Per Colonoscopy
研究概览
简要总结
Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure
详细描述
Recent studies indicate that continuing medical education, time of colonoscopy during the day, forced longer withdrawal time, use of high definition colonoscopes all result in improving ADR although the gains have only been modest. To this end, adding novel devices to the tip of colonoscope may improve the ability of doctors to perform a better procedure. We therefore propose to identify the increase in ADR with 3 of these devices compared to standard colonoscopy. Fuse colonoscopy (2 cameras embedded at the side of the colonoscope tip providing an increased angle of view), EndoCuff (a plastic cap to fit the tip with flexible arms which hold the mucosa back aiding in inspection), EndoRings (similar to EndoCuff but the arms are wider) have been shown in tandem colonoscopy studies to improve the adenoma miss rates to 7-15% instead of the miss rates seen with standard colonoscopy which is usually about 40%. All these devices are FDA approved and are distributed in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
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
- •Screening or Surveillance Colonoscopy
排除标准
- •Personal history of Colorectal cancer or Inflammatory bowel disease
- •Surgical resection of the colon or known colonic stricture
- •Personal or family history of Polyposis syndromes or Lynch syndrome
- •Referral for incomplete colonoscopy or known therapeutic polyp clearance
- •Severe diverticular disease
- •Referral for a positive hemoccult test in the past 6 months
- •Known coagulopathy
- •Inability to provide informed consent
研究组 & 干预措施
FUSE® Colonoscopy
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
干预措施: FUSE® Colonoscopy (Device)
Colonoscopy with EndoCuff™
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
干预措施: Colonoscopy with EndoCuff™ (Device)
Colonoscopy with EndoRings™
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
干预措施: Colonoscopy with EndoRings™ (Device)
Standard Colonoscopy
A standard colonoscope will be used to complete the procedure
干预措施: Standard Colonoscopy (Device)
结局指标
主要结局
Adenomas Per Colonoscopy
时间窗: During Procedure
次要结局
- Inspection Time(During Procedure)
- Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.(During Procedure)
- Percentage of Participants With Detected Sessile Serrated Polyp(During Procedure)
- Number of Participants With a Detected Polyp(During Procedure)
- Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion(During Procedure)
- Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.(During Procedure)
- Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.(During Procedure)
- Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.(During Procedure)
- Number of Participants With Detected Adenoma(During Procedure)
- Percentage of Participants With Detected Adenoma(During Procedure)
- Sessile Serrated Polyps Per Colonoscopy(During Procedure)
- Percentage of Participants With a Detected Polyp(During Procedure)
- Number of Participants With Detected Sessile Serrated Polyp(During Procedure)
- Cecal Insertion Time(During Procedure)
研究者
Douglas K. Rex
Professor
Indiana University