Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,410
- 试验地点
- 12
- 主要终点
- Difference in Adenomas Per Colonoscopy (APC)
研究概览
简要总结
This is a prospective, multicenter, randomized controlled study to evaluate the effect of the Computer-Assisted Detection (CADe) Device on Adenomas Per Colonoscopy and Positive Percent Agreement for routine colonoscopies. The control arm is colonoscopy performed with High Definition White Light Endoscopy (HD-WLE) per standard of care. The intervention arm is colonoscopy performed with HD-WLE per standard of care plus the Computer-Assisted Detection (CADe) Device.
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 (Outcomes Assessor)
盲法说明
Subjects, investigators, study site personnel, and pathologists will not be blinded to treatment assignments. All Verily personnel involved in the statistical analysis of this study will be blinded to treatment assignment. For the interim analysis, unblinded analysis will be performed by an independent statistician, the results of which will be communicated to a select group of Verily personnel not involved in the study management.
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scheduled to undergo routine screening (including, but not limited to, FIT/Cologuard positive), routine surveillance (≥3 years as scheduled since last colonoscopy), or diagnostic (symptomatic) colonoscopy with High Definition White Light Endoscopy.
- •Between the ages of 45 and 80 years, inclusive
- •Able and willing to provide written informed consent
排除标准
- •Self-reported pregnancy
- •Known diagnosis of Colorectal Cancer
- •History of, or referral for, Inflammatory Bowel Disease
- •Previous surgery involving the colon or rectum
- •Referral for known polyp or assessment of post-polypectomy site (i.e. less than 3 years since last colonoscopy).
- •High suspicion or diagnosis of genetic polyposis syndromes, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), or any other high-risk family history meeting Bethesda guidelines.
- •Referral for overt, symptomatic gastrointestinal bleeding
结局指标
主要结局
Difference in Adenomas Per Colonoscopy (APC)
时间窗: Day 1
Difference in Adenomas Per Colonoscopy (APC) between the control and intervention arm, evaluated for superiority. APC is defined as the average number of histologically confirmed adenomas resected per colonoscopy.
Difference in Positive Percent Agreement (PPA)
时间窗: Day 1
Difference in Positive Percent Agreement (PPA) between the control and intervention arm, evaluated for non-inferiority. PPA is defined as the total number of histologically confirmed Clinically Significant Excised Lesions, divided by the total number of excisions.
次要结局
- Adenoma Detection Rate (ADR)(Day 1)
- Number of False Alerts Per Procedure(Day 1)
- Mean Withdrawal and Inspection Time (MWT)(Day 1)
- Polyp Detection Rate (PDR)(Day 1)
- Proximal Adenoma Detection Rate (pADR)(Day 1)
- Flat Adenoma Detection Rate (fADR)(Day 1)
- Serrated Lesions Per Colonoscopy (SLPC)(Day 1)
- Serrated Lesions Detection Rate (SLDR)(Day 1)
- Adenoma Detection Rate Including Carcinoma (ADR*)(Day 1)
- Small Adenoma Detection Rate (sADR)(Day 1)
- Polyps Per Colonoscopy (PPC)(Day 1)
- Advanced Adenoma Detection Rate (aADR)(Day 1)
- False Positive Rate (FPR)(Day 1)