Assessment the Performance of PillCam SB3 Capsule in Detecting Small Bowel Lesions in Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 4
- 主要终点
- Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians
研究概览
简要总结
Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality, and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps, which will create more images for evaluation, and therefore should improve diagnostic accuracy.
Proposed Design: to enroll up to 230 patients with symptoms suggesting the presence of small bowel disease.
Preparation for procedure will include 12 hours fasting prior to the capsule ingestion
Patients will undergo a standard capsule endoscopy. Patients will be allowed to drink clear liquids 2 hours post ingestion, and eat 4 hours post ingestion.
Diagnostic yield of the SB3 will be calculated The Physician's subjective assessment of capsule performance will be captured
详细描述
- Purpose of study- To assess the performance of PillCam SB3 capsule in detecting small bowel lesions in patients
- Study design- Feasibility study
- Number of subjects- Up to 200
- Subject population- Patients with symptoms suggestive of small bowel disease and whom are eligible and indicated for SB capsule endoscopy
- No of centers- 4
- Duration of enrollment up to 12 months from IRB approval to enroll study patients
- Duration of follow-up 1 week after capsule procedure.
- Primary objectives To evaluate the performance of SB-3 system in patients as per physician questionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
capsule endoscopy
干预措施: capsule endoscopy (Device)
结局指标
主要结局
Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians
时间窗: up to 6 months from end of recruitment
precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians
次要结局
未报告次要终点