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临床试验/NCT01370759
NCT01370759终止1 期

Flocculation-Adsorption System for Colon Cleansing Enhancement: A Feasibility Study

Medtronic - MITG1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2011年9月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
终止
入组人数
81
试验地点
1
主要终点
Cleansing grading

研究概览

简要总结

The purpose of this study is to demonstrate feasibility of enhancing colon cleansing.

详细描述

To ensure the success of a PillCamTM Colon examination, as standard practice, patients are requested to adhere to a bowel preparation procedure.

The study is designed to evaluate the performance and contribution of a flocculation-adsorption system to colon cleansing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
23 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject's age is between 23-75 years.
  • Subject is healthy.
  • Subject agrees to sign the Informed Consent Form

排除标准

  • Contraindication to capsule endoscopy
  • Contraindication or allergy to any of the products and materials used for bowel preparation
  • Subject is not able to provide written informed consent

研究组 & 干预措施

Colon-targeted cleaning capsule

Experimental

干预措施: Cleaning capsule (Other)

结局指标

主要结局

Cleansing grading

时间窗: within 10 days

次要结局

  • Distribution of time(within 10 days)
  • GI tract segment of capsule disintegration(within 10 days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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