Enhancing Polyp Detection: A Randomized Controlled Trial Comparing Combined Computer-Aid Detection and Polyp-Detecting Colonoscope Attachment to Computer-Aid Detection Alone in Patients Undergoing Colonoscopy.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,766
- 试验地点
- 2
- 主要终点
- Adenoma detection rate
研究概览
简要总结
Despite the widespread use of colonoscopy, the ongoing challenge of potentially missing polyps remains. Previous studies have independently shown that both Endocuff, a colonoscope attachment device for polyp detection, and Computer-Aided Detection (CADe) systems have individually demonstrated enhanced lesion detection and safety. This study seeks to evaluate the efficacy of combining the Endocuff CADe versus using CADe alone in colonoscopy procedures for colorectal cancer screening and surveillance. This research project aims to ascertain whether the synergistic application of these technologies yields superior outcomes.
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
- Double (Participant, Outcomes Assessor)
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
- •Age > 18
- •Patients scheduled for an outpatient screening or surveillance colonoscopy.
排除标准
- •Patients who require diagnostic colonoscopy (e.g.; anemia or GI bleeding).
- •Patients requiring deep ileal intubation.
- •Patients with inflammatory bowel disease.
- •Patients with radiotherapy-induced colitis or other severe colitis.
- •Patients with colonic strictures.
- •Patients with acute diverticulitis.
- •Patients with large bowel obstruction.
- •Patients scheduled for therapeutic colonoscopy (e.g., planned endoscopic mucosal resection for known polyps).
- •Patients scheduled for assessment of a known colonic lesion.
- •Patients with a known history of hereditary polyposis syndrome or untreated colon cancer.
- •Patients with a history of colon resection.
- •Patients on continuous anti-thrombotic therapy
- •Pregnancy.
- •Patients who are ineligible for colonoscopy due to medical or psychiatric conditions.
- •Patients who are vulnerable or unable to consent
结局指标
主要结局
Adenoma detection rate
时间窗: 18 months
It is the percentage of patients who have at least one adenoma detected during the colonoscopy
次要结局
- Cecal intubation time(18 months)
- Colonoscopy withdrawal time(18 months)
- Differences in polyps size(18 months)
- Polyp detection rate(18 months)
- Cecal intubation rate(18 months)
- Polyps location (cecum, ascending, transverse, descending, sigmoid, or rectum)(18 months)
- Procedure complication (bleeding or perforation) by the end of the procedure. (Following lexicon for endoscopic adverse events methods)(18 months)
- Number of cancerous lesions(18 months)
- Differences in polyps histology between the groups(18 months)
研究者
Wesam Frandah
Associate Professor
Marshall University