Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy: Prospective, Randomized Clinical Performance Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 830
- 试验地点
- 8
- 主要终点
- Adenomas per Colonoscopy (APC)
研究概览
简要总结
This is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening or surveillance of colorectal Cancer (CRC).
Eligible subjects who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to undergo colonoscopy :
- Experimental: CADe colonoscopy procedure with WISE VISION® Endoscopy (CADe Group)
- Control: Standard Colonoscopy without CADe (Standard Colonoscopy Group)
详细描述
This study aims to evaluate whether NEC WISE VISION® Endoscopy enhances the ability to detect mucosal lesions when compared with the current standard-of-care procedure (high-definition white light [HDWL] colonoscopy). The CADe device, Wise VISION® Endoscopy, contains an artificial intelligence/machine learning (AI/ML) advanced algorithm to aid the endoscopists in detection of colonic lesions.
This study plans to enrol 830 subjects aged ≥ 45 years and < 75 years, who are scheduled for screening or surveillance colonoscopy.
After review of the inclusion and exclusion criteria, eligible subjects will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADe Group) or standard colonoscopy without CADe (Standard Colonoscopy Group).
All adenomas, that are identified during the colonoscopies, will be removed and biopsied as per standard clinical practice to assess adenoma miss rate, polyp miss rate, adenomas per colonoscopy and other endpoints.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is presenting to the endoscopy unit for colon cancer screening or surveillance colonoscopy.
- •Signed Informed Consent
排除标准
- •Contraindications to colonoscopy
- •Colonoscopy within the previous three (3) years
- •High-risk indications for colonoscopy
- •Antithrombotic therapy that cannot be stopped, precluding polyp resection
- •Inflammatory bowel disease
- •Referred for endoscopic mucosal resection (EMR)
- •Familial adenomatous polyposis syndrome or Serrated Polyposis Syndrome
- •Pregnant or planning a pregnancy during the study period
结局指标
主要结局
Adenomas per Colonoscopy (APC)
时间窗: during the procedure/surgery
Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
次要结局
未报告次要终点