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Completed

NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Olympus Elite

Device

New generation Olympus endoscope

Olympus Spectrum

Device

Current generation Olympus endoscope

Primary outcomes

  1. Sensitivity

    Time frame: Baseline and 1 day

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

Secondary outcomes

  1. Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.

    Time frame: Baseline and 1 day

    Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.

  2. Sensitivity of Dual Focus technology

    Time frame: Baseline and 1 day

    Difference in sensitivity of lesion characterisation when using dual focus technology.

  3. Endoscopists confidence

    Time frame: Baseline and 1 day

    Difference in endoscopists' confidence scores in lesion characterisation between new and current technologies.

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Registry information

Acronym: ELITE

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 8, 2017
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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