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临床试验/NCT02852161
NCT02852161已完成不适用

The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study

University of Nottingham1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年7月1日最近更新:
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
50
试验地点
1
主要终点
Diagnostic accuarcy

研究概览

简要总结

A pilot study to assess the accuracy and acceptability of a magnet assisted capsule endoscopy in detecting esophageal pathology compared to standard endoscopy.

详细描述

This will be a single centre feasibility study performed at Nottingham University Hospitals NHS Trusts.

We will assess the accuracy of MACE compared to gastroscopy in diagnosing Barretts oesophagus and esophageal varices. Patients will have both tests on the same ay, with the endoscopic findings compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Investigator)

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

  • •Due to have a clinically indicated gastroscopy Barrett's oesophagus/ oesophageal varices or Controls Able to give informed consent

排除标准

  • •Unable to give consent Pregnant Pacemaker swallowing difficulties

研究组 & 干预措施

MACE

Experimental

MACE procedure

干预措施: Magnet assissted capsule endoscopy (Device)

OGD

Active Comparator

Clinically indicated gastroscopy

干预措施: Magnet assissted capsule endoscopy (Device)

结局指标

主要结局

Diagnostic accuarcy

时间窗: immediate

endoscopic

次要结局

  • comfort(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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