Performance Evaluation of the NaviCam SB Capsule Endoscope System in Comparison to the PillCam SB3 Capsule System for the Diagnosis of Small Bowel Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Diagnostic agreement rate
研究概览
简要总结
This study uses a comparative method to evaluate the performance of the NaviCam SB capsule endoscope system in comparison to the PillCam SB3 capsule system for the diagnosis of small bowel diseases.
详细描述
This study adopts a prospective and self-controlled design. The subjects are adult patients (≥18 years old) who have symptoms of small bowel disease or suspected GI bleeding; Subjects swallow two types of SB capsules approximately 40 minutes apart in a randomized order. During the capsule endoscopy, the doctor can view the small bowel images taken by the capsules in real time. This study adopts a method of independent image reading in the participating centers. Two physicians of digestive endoscopy respectively review the images captured by the experimental capsule and the control capsule for normal versus abnormal findings, type of findings and categorization (lesions, polyps, bleeding, etc.), capsule transit time, reading time, and image quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Adult patients (≥18 years old) who have symptoms of small bowel disease or suspected GI bleeding;
- •Those need capsule endoscopy because the recurring GI symptoms cannot be explained by other imaging methods;
- •Those can understand and accept this study protocol and voluntarily sign an informed consent.
排除标准
- •Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule;
- •Patient with known gastrointestinal motility disorders;
- •Patient with known or suspected gastrointestinal obstruction, stenosis or fistula;
- •Patient with known or suspected delayed gastric emptying;
- •Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions;
- •Patient has any allergy or other known contraindication or intolerance to the medications used in the study;
- •Patient has any condition, which precludes compliance with study and/or device instructions;
- •Women who are either pregnant or nursing at the time of screening;
- •Concurrent participation in another clinical trial using any investigational drug or device;
- •Patient suffers from a life-threatening condition;
- •Patients with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters;
- •Patients with pace-maker or implantable cardioverter other implantable electronic medical device;
- •Patient with an easily magnetized metal part;
- •Patient requires endoscopic placement of the capsule;
- •Others considered by the investigator not suitable for this study.
结局指标
主要结局
Diagnostic agreement rate
时间窗: 14 days
The diagnosis of subjects by the two types of small bowel capsule endoscopes through independent image reading, that is, the agreement between the two systems with respect to the diagnosis of normal or abnormal subject.
次要结局
- diagnosis rate(14 days)
- Intestinal transit time(14 days)
- Quality of small bowel images(14 days)
- Ease of swallowing the capsule(14 days)
- Image reading time(14 days)