A Multicenter, Prospective Study of Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 482
- 试验地点
- 24
- 主要终点
- Diagnostic accuracy of ACG in screening for common UGI abnormalities
研究概览
简要总结
The goal of this clinical trial is to evaluate the diagnostic accuracy of the AI-integrated Capsule Gastroscopy (ACG) system in simulated home-use conditions for detecting upper gastrointestinal (UGI) abnormalities. It will also compare the diagnostic accuracy and time efficiency of AI-assisted interpretation versus manual reading of ACG data. The main questions it aims to answer are:
What is the diagnostic accuracy of the ACG system, using conventional esophagogastroduodenoscopy (EGD) as a standard of reference?
Does AI-assisted ACG reading improve diagnostic accuracy or reduce reading time compared to manual ACG video reading?
Researchers will compare ACG results to conventional EGD findings (standard of reference) to determine if ACG can serve as a reliable method for UGI disease detection in home scenarios.
Participants will:
Undergo an ACG examination in a simulated home environment. Complete an EGD procedure within 24 hours post-ACG ingestion.
详细描述
Gastroscopy stands as the gold standard for diagnosis of upper gastrointestinal (UGI) diseases (1, 2). However, China faces a significant challenge due to its large population base and an insufficient number of gastrointestinal endoscopists, which limits the widespread adoption of conventional electronic gastroduodenoscopy (EGD). Additionally the discomfort associated with EGD and the low compliance rate reduce its effectiveness in meeting public health needs (3).
Capsule endoscopy (CE), primarily comprising magnetic capsule endoscopy (MCE) and powerless capsule endoscopy (PCE), is an innovative medical technology that enables comfortable and comprehensive examinations of the digestive tract (4-6). MCE relies on costly magnetic guidance equipment for capsule manipulation (7), a process that requires specialized technicians. These inherent limitations pose barriers to its clinical use and acceptance in various settings, such as primary hospitals and community health centers.
To overcome these challenges, we have developed an automated, wireless, artificial intelligent (AI) integrated Capsule Gastroscopy (ACG) System (GICE-1000, AI Mobile Gastroscopy, Guangzhou Side Medical Technology Co., Ltd) for detecting gastric lesions. After the stomach is distended with ingested, the capsule examines the entire stomach through standardised body position changes by the participant, eliminating the need for any magnetic guidance equipment. The video sequence can be viewed in real-time using a cellphone and transmitted via WIFI to a cloud server for remote reading. Characterized by its comfort, operational simplicity, and remote controllability, GICE-1000 is poised to enhance the early detection and treatment rate of UGI abnormalities in different settings, including both community hospitals and homes, thereby alleviating healthcare system burdens. However, there is no prospective study to assess the diagnostic accuracy of GICE-1000 in home scenarios.
The study is structured into three distinct phases: the screening period, the examination period, and the follow-up period.
- Screening Period:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Aged 18 years or older.
- •Individuals meeting the following criteria:
- •i. Healthy volunteers; ii. Suspected presence of gastrointestinal diseases, with one or more of the following clinical symptoms: abdominal pain, nausea, vomiting, hematemesis, black or bloody stools, loss of appetite, bloating, or indigestion; iii. Follow-up of gastric lesions post-endoscopic resection.
- •Willing to participate voluntarily in the clinical trial and provide written informed consent.
- •Capable of communicating with researchers and complying with trial requirements.
排除标准
- •Pregnant individuals.
- •Individuals at high risk of gastrointestinal obstruction, including those identified as being at risk of gastrointestinal stenosis based on the Gastrointestinal Stenosis Assessment Form, those in whom gastrointestinal obstruction cannot be clinically excluded, or individuals with a history of gastrointestinal surgery, severe motor dysfunction, or pseudobulbar palsy.
- •Individuals with swallowing dysfunction.
- •Individuals deemed unfit for surgery or unwilling to undergo any surgical procedures.
- •Participants who are unable to comprehend and/or comply with physician instructions during the examination.
- •Individuals with other medical risks that contraindicate the use of a capsule gastric endoscopy system, or those deemed unsuitable for participation in this study at the discretion of the investigator.
研究组 & 干预措施
Testing Group
Product name: Gastric Capsule Endoscope System Specification model: GICE-1000 Manufacturer: Guangzhou Side Medical Technology Co., Ltd. Participants fast for at least 8 hours and take mucolytics and anti-foaming agents 30 minutes before the ACG. Following video instructions, they connect the capsule with mobile, activate the capsule, and swallow it with water. Participants remain blinded to real-time ACG video. Researchers observe and record whether the participants have completed the examination as instructed in the video and any adverse events (without guidance). Data will be uploaded post-exam via WiFi or the manufacturer's system. Capsule discharge will be tracked.
干预措施: AI-integrated Capsule Gastroscopy (ACG) examination (Device)
Control group
Product name: Electronic gastrointestinal endoscope (EGD) Specifications and models: GIF-290 series Manufacturer: Olympus, Tokyo, Japan EGD was the reference standard against which ACG was compared, and it was performed within 24 hours post-ACG ingestion time. Participants will fast for at least 8 hours (clear water is allowed) and take mucolytics and anti-foaming agents 30 minutes before the EGD.
The EGD will then be performed by endoscopists with more than 500 EGD procedures completed, who are blinded to the ACG examination results. The procedure for this study will adhere to the Systematic Screening Protocol for the Stomach (SSS), as outlined by Yao et al(8).The endoscopists will record any lesions identified (including lesion type, location, size, number of lesions etc.), and biopsies or treatments will be performed following white-light EGD screening, if necessary. Anonymous reports, images, and videos will be exported for further analysis.
干预措施: Electronic gastroduodenoscopy (EGD) examination (Device)
结局指标
主要结局
Diagnostic accuracy of ACG in screening for common UGI abnormalities
时间窗: Through study completion, an average of 1 year.
EGD will serve as the reference standard. Metrics such as sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, diagnostic agreement rate, positive agreement rate (PAR), negative agreement rate (NAR), and diagnostic agreement rate of each individual lesion will be calculated. A participant will be classified as positive if any lesions are detected, including but not limited to: chronic atrophic gastritis, gastric ulcer, gastric polyps, gastric dysplasia, gastric masses, gastric cancer, gastric hemorrhage and other gastric lesions. Esophageal abnormalities (reflux esophagitis, Barrett's esophagus, esophageal cancer, esophageal masses and other abnormalities), duodenal abnormalities (duodenal ulcer, duodenal polyps, hemorrhage and other abnormalities). If no lesions are detected, or only chronic superficial gastritis is observed, the participant will be classified as negative.
次要结局
- Evaluation of image quality of ACG(Through study completion, an average of 1 year.)
- Diagnostic accuracy and average diagnostic time between AI-assisted reading and manual reading of ACG(Through study completion, an average of 1 year.)
- Coverage rate of gastric anatomical sites of ACG(Through study completion, an average of 1 year.)
- Inspection completion rate of ACG(Through study completion, an average of 1 year.)
- Average duration of ACG(Through study completion, an average of 1 year.)
- Average inspection time of ACG(Through study completion, an average of 1 year.)
- 72-hour discharge rate of ACG(Through study completion, an average of 1 year.)
- Lesion detection rate of ACG(Through study completion, an average of 1 year.)
- Satisfaction evaluation of ACG(Through study completion, an average of 1 year.)
- Evaluation of gastric cleanliness of ACG(Through study completion, an average of 1 year.)
- Evaluation of gastric filling of ACG(Through study completion, an average of 1 year.)
- Evaluation of degree of gastric mucosal visualization of ACG(Through study completion, an average of 1 year.)