NCT03073226

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Portsmouth Hospitals NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Barrett Esophagus
• Polyps

Interventions

Type	Name	Description
DEVICE	Olympus Elite	New generation Olympus endoscope
DEVICE	Olympus Spectrum	Current generation Olympus endoscope

Timeline

• Start date: 2016-02-06
• Primary completion: 2017-11-01
• Completion: 2018-02-06
• First posted: 2017-03-08
• Last updated: 2019-06-27

Locations

1 site across 1 country: United Kingdom