NCT02775708已完成不适用
Development of Applications of the ® PillCam Endoscopy System and Evaluation of Their Performance
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 3
- 主要终点
- Number of gaps in the RAPID video will be assessed
研究概览
简要总结
The purpose of this study is to support development of PillCam Endoscopy System applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Subject's from 18 years of age.
- •Subject is indicated for Capsule Endoscopy procedure.
- •Subject agrees to sign the Informed Consent Form.
排除标准
- •Female subject is pregnant.
- •Subject is known or is suspected to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting).
- •Subject has a pacemaker or other implanted electro-medical device.
- •Subject has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems.
- •Subject suffers from life threatening conditions.
- •Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study
研究组 & 干预措施
capsule endoscopy
Experimental
open label arm ; up to 100 subjects indicated for capsule endoscopy (CE) procedure will undergo the CE procedure with the Pillcam endoscopy system
干预措施: Pillcam endoscopy system (Device)
结局指标
主要结局
Number of gaps in the RAPID video will be assessed
时间窗: capsule endoscopy procedure day
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
相似试验
终止
不适用
Development of Applications of PillCam™ Endoscopy and Patency Systems and Clinical Evaluation of Their Performance in Healthy Volunteers ("HEIGHT" Study)HealthyNCT03301909Medtronic - MITG694
已完成
不适用
Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the ColonColorectal LesionsNCT01269372Medtronic - MITG30
已完成
不适用
Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the ColonCRC ScreeningNCT01372878Medtronic - MITG884
终止
1 期
Evaluation of PillCam With Blood-Sensing Feature: A Feasibility StudyUpper GI BleedingNCT01448382Medtronic - MITG39
已完成
不适用
Evaluation of PillCam® Express Capsule Endoscopy Delivery SystemSmall Bowel DiseaseInflammatory Bowel DiseaseNCT01088646Medtronic - MITG25