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临床试验/NCT01740349
NCT01740349已完成不适用

EVALUATION OF THE PILLCAM™ COLON CAPSULE ENDOSCOPY (PCCE) IN PEDIATRIC ULCERATIVE COLITIS

Azienda Policlinico Umberto I1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年8月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This prospective pilot study of 30 pediatric subjects, that are indicated for standard colonoscopy due to follow-up of ulcerative colitis (UC), examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy.

This study aims

  1. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.
  2. To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 18 Years（Child, 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

结局指标

主要结局

To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.

时间窗: Day 3 (after colonoscopy and CCE-2)

Accuracy parameters (sensitivity, specificity, NPV, PPV) of PCCE compared to standard colonoscopy in pediatric Ulcerative Colitis.

次要结局

  • To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.(Day 3 (after colonoscopy and CCE-2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Di Nardo

EVALUATION OF THE PILLCAM™ COLON CAPSULE ENDOSCOPY (PCCE) IN PEDIATRIC ULCERATIVE COLITIS

Azienda Policlinico Umberto I

研究点 (1)

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