Development and Validation of an Artificial Intelligence System for Detection and Characterization of Small Bowel Mucosal Atrophy in Celiac Disease and Non-Celiac Enteropathies: A Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Diagnostic Performance of the AI System
研究概览
简要总结
Coeliac disease (CD) is an immune-mediated enteropathy leading to small intestinal mucosal atrophy. Diagnosis relies on serology and duodenal biopsies, but it can be complicated by patchy lesions and differential diagnosis with Non-Celiac Enteropathies (NCEs). This multicenter observational study aims to develop and validate an Artificial Intelligence (AI) system to detect and characterize small bowel mucosal atrophy and other pathological findings using endoscopic imaging. The study involves a retrospective phase for training the AI model and a prospective phase to validate its diagnostic accuracy compared to standard human assessment.
详细描述
The study is a multicenter observational non-profit study with a total expected duration of 36 months. It aims to address the challenges in diagnosing CD and NCEs, specifically the subjective nature of endoscopic evaluation and inter-observer variability.
The study proceeds in two phases:
- Model Development (Retrospective): Training of Deep Learning algorithms on anonymized endoscopic images/videos to identify mucosal atrophy and other lesions (e.g., angiodysplasia, ulcers, polyps).
- Validation (Prospective): Enrolling patients undergoing small bowel endoscopy to validate the AI system's performance.
The system aims to provide analysis to assist endoscopists, reducing missed lesions and improving diagnostic accuracy.
Validation of the AI system will be performed offline on recorded anonymized endoscopy videos collected prospectively during the validation phase.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥18 years).
- •Patients undergoing endoscopic investigation of the small bowel (endoscopy or capsule endoscopy)
排除标准
- •Inability to provide informed consent.
研究组 & 干预措施
Enteropathy Cohort (CD/NCE)
Adult patients (>=18 years) with suspected or confirmed Celiac Disease or Non-Celiac Enteropathies undergoing small bowel endoscopy.
Control Cohort
Adult patients (>=18 years) undergoing small bowel endoscopy who do not have enteropathy or other small bowel pathological lesions (negative controls).
Other Small Bowel Lesion Cohort
Adult patients (>=18 years) undergoing small bowel endoscopy who who do not have Celiac Disease or Non-Celiac Enteropathies but have other small bowel pathological lesions.
结局指标
主要结局
Diagnostic Performance of the AI System
时间窗: Through study completion (36 months)
Evaluation of Accuracy, Sensitivity, and Specificity of the AI system in detecting intestinal mucosal atrophy and other major pathological findings compared to the gold standard (histology/expert consensus).
次要结局
- Comparison of Diagnostic Performance (No AI-assistance vs AI-assisted)(Through study completion (36 months))
- Inter-observer Agreement(Through study completion (36 months))