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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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03073226
Acronym
ELITE
Enrollment
232
Registered
2017-03-08
Start date
2016-02-06
Completion date
2018-02-06
Last updated
2019-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett Esophagus, Polyps

Brief 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.

Interventions

DEVICEOlympus Elite

New generation Olympus endoscope

DEVICEOlympus Spectrum

Current generation Olympus endoscope

Sponsors

Portsmouth Hospitals NHS Trust
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
SensitivityBaseline and 1 dayDifference in the sensitivity of in vivo lesion characterisation between Lucera Elite vs Lucera Spectrum as compared to final histology.

Secondary

MeasureTime frameDescription
Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.Baseline and 1 dayDifference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.
Sensitivity of Dual Focus technologyBaseline and 1 dayDifference in sensitivity of lesion characterisation when using dual focus technology.
Endoscopists confidenceBaseline and 1 dayDifference in endoscopists' confidence scores in lesion characterisation between new and current technologies.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026