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临床试验/NCT00204763
NCT00204763终止4 期

Comparison of Solid-State Esophageal Manometry and Water Perfused Anorectal Manometry Catheters With Air Filled Multi-Balloon Esophageal and Anorectal Manometry Catheters

University of Utah2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
4 期
状态
终止
入组人数
5
试验地点
2
主要终点
To compare the accuracy of esophageal and anorectal manometric pressure measurements using a newly developed air filled balloon catheter with present standard solid state esophageal and anorectal catheters

研究概览

简要总结

The primary objective of this study is to compare the accuracy of esophageal and anorectal manometric pressure measurements using a newly developed air filled balloon catheter with present standard solid state esophageal and anorectal catheters, respectively.

详细描述

Twenty subjects with abnormal esophageal motility (5 subjects each with achalasia, nutcracker esophagus, scleroderma, diffuse esophageal spasm or hypertensive LES) previously referred for clinical esophageal motility testing will be contacted. These twenty subjects must have previously undergone esophageal manometry testing using the standard clinical protocol at the University of Utah motility with solid state manometry catheters. After obtaining informed consent, these twenty subjects will undergo the esophageal manometry using air-filled balloon catheters per the standard clinical protocol. Following the repeat procedure a short one-page questionnaire will be completed by the subject and the motility nurse.

Five subjects with the diagnosis of incontinence previously referred for clinical anorectal motility testing will be contacted. These five subjects must have previously undergone anorectal manometry using the standard clinical protocol for an anorectal manometry study with water perfused anorectal manometry catheters. After obtaining informed consent, these five subjects will undergo the anorectal manometry using air-filled balloon catheters per the standard clinical protocol. Following the repeat procedure a short one-page questionnaire will be completed by the subject and the motility nurse.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18-80 years old
  • Ability to give informed consent
  • No significant medical conditions
  • Abnormal esophageal motility
  • Abnormal anorectal motility

排除标准

  • Previous esophageal or anorectal surgery, anatomic abnormalities or dysfunction

结局指标

主要结局

To compare the accuracy of esophageal and anorectal manometric pressure measurements using a newly developed air filled balloon catheter with present standard solid state esophageal and anorectal catheters

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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