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临床试验/NCT03073226
NCT03073226已完成不适用

A Prospective Study Comparing the Accuracy of Olympus Lucera Spectrum Technology vs Olympus Lucera Elite Technology in the in Vivo Diagnosis of Barrett's Oesophagus and Colorectal Polyps: The ELITE Study

Portsmouth Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2016年2月6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
232
试验地点
2
主要终点
Sensitivity

研究概览

简要总结

Barrett's oesophagus is a condition where the lining of the oesophagus (gullet) wall changes. People with Barrett's oesophagus are at risk of developing oesophageal cancer but can have regular checkups to detect changes before they progress to cancer. Every two years patients with Barrett's are offered examination by passing a fibreoptic tube into the oesophagus (gastroscopy) to remove small tissue samples (biopsies), which are examined in the laboratory to check for changes.

Bowel cancer is the third most common cancer in the UK, and the second leading cause of cancer deaths. Prevention and early detection are the most effective strategies of dealing with bowel cancer. Most cancers develop from benign polyps (growths) in the bowel. Polyps are common and have the potential of developing into cancer over the course of many years.

Patients with a prior diagnosis of Barrett's oesophagus and colonic polyps undergo regular endoscopic examinations known as surveillance endoscopies. This is done to detect changes in the cells of Barrett's oesophagus or further polyps. Current practice is to capture recorded videos of Barrett's surveillance examinations and still images of polyps prior to their removal.

Endoscope technology continues to advance. These newly developed technologies are marketed to have claims of superiority in performance over preceding generations often without the back up of scientific data but at a significant financial cost. The aim of this study is to use endoscopic images and videos recorded as part of routine clinical practice to compare the current version of Olympus endoscopes with the new version launched by the company.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Diagnostic
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

入选标准

  • Patients attending for Barrett's surveillance OR
  • Patients attending for colonic polyp surveillance or screening
  • Patients are willing and able to give informed consent.

排除标准

  • Polyp syndromes (eg FAP or Lynch Syndrome)
  • Known history of IBD

研究组 & 干预措施

Barrett's Surveillance Olympus Elite

Experimental

Barrett's surveillance with Olympus ELITE.

干预措施: Olympus Elite (Device)

Barrett's surveillance Olympus Spectrum

Experimental

Barrett's surveillance with Olympus Spectrum.

干预措施: Olympus Spectrum (Device)

Polyp Surveillance Olympus Spectrum

Experimental

Colonic polyp surveillance/screening with Olympus Spectrum.

干预措施: Olympus Spectrum (Device)

Polyp Surveillancewith Olympus ELITE.

Experimental

Colonic polyp surveillance/screening with Olympus ELITE.

干预措施: Olympus Elite (Device)

结局指标

主要结局

Sensitivity

时间窗: Baseline and 1 day

Difference in the sensitivity of in vivo lesion characterisation between Lucera Elite vs Lucera Spectrum as compared to final histology.

次要结局

  • Endoscopists confidence(Baseline and 1 day)
  • Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.(Baseline and 1 day)
  • Sensitivity of Dual Focus technology(Baseline and 1 day)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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