Clinical Investigation of the ColoMaia II Software for Supporting Lesion Detection During Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Adenoma Detection Rate (ADR)
研究概览
简要总结
The goal of this clinical trial is to learn whether the ColoMaia II software can help doctors find colon lesions during colonoscopy and whether it is safe to use in adults aged 40 to 80 years having screening, surveillance, or diagnostic colonoscopy. The main questions it aims to answer are whether the software increases the number of participants in whom at least one adenoma is found, and whether the software is safe to use during colonoscopy. Researchers will compare colonoscopy with ColoMaia II software assistance to standard colonoscopy without the software. Participants will be assigned to a colonoscopy with or without ColoMaia II software assistance, have a colonoscopy performed by a qualified physician, have tissue samples examined if needed, and allow study data and procedure videos to be collected and reviewed.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40-80 years, indicated for screening, surveillance, or diagnostic colonoscopy.
排除标准
- •Patients with active inflammatory bowel disease, known familial polyposis, contraindication to polypectomy, personal history of colorectal cancer (CRC), prior resection of the colon, patients who do not provide informed consent.
研究组 & 干预措施
ColoMaia II-Assisted Colonoscopy
干预措施: ColoMaia II software (Device)
Standard Colonoscopy
干预措施: Standard colonoscopy (Procedure)
结局指标
主要结局
Adenoma Detection Rate (ADR)
时间窗: Periprocedural
Proportion of participants with at least 1 adenoma detected, removed, and histologically verified during the index colonoscopy.
Incidence of Serious Adverse Device Effects (SADE)
时间窗: Periprocedural
Number of serious adverse events considered to have a causal or reasonably possible relationship to the ColoMaia II software.
次要结局
- Usability Questionnaire Score(Immediately after the index colonoscopy procedure)
- Adenomas Per Colonoscopy (APC)(Periprocedural)
- Positive Percent Agreement (PPA) for Clinically Significant Lesions(Periprocedural)
- Visual Alert Sensitivity for Pre-specified Detection Delays(Periprocedural)
- Acoustic Alert Sensitivity for Pre-specified Detection Delays(Periprocedural)
- False Acoustic Alerts per Minute(Periprocedural)
- Erroneous Visual Alerts per Minute(Periprocedural)
- Average Alert Delay(Periprocedural)
- Average Percentage of Time With an Incorrect Visual Alert(Periprocedural)