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

NCT ID: NCT03073226

Last Updated: 2019-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-06
• Study Completion Date: 2018-02-06

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.

Conditions

Barrett Esophagus; Polyps

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Barrett's surveillance Olympus Spectrum

Barrett's surveillance with Olympus Spectrum.

Group Type: EXPERIMENTAL

Olympus Spectrum

Intervention Type: DEVICE

Current generation Olympus endoscope

Barrett's Surveillance Olympus Elite

Barrett's surveillance with Olympus ELITE.

Group Type: EXPERIMENTAL

Olympus Elite

Intervention Type: DEVICE

New generation Olympus endoscope

Polyp Surveillance Olympus Spectrum

Colonic polyp surveillance/screening with Olympus Spectrum.

Group Type: EXPERIMENTAL

Olympus Spectrum

Intervention Type: DEVICE

Current generation Olympus endoscope

Polyp Surveillancewith Olympus ELITE.

Colonic polyp surveillance/screening with Olympus ELITE.

Group Type: EXPERIMENTAL

Olympus Elite

Intervention Type: DEVICE

New generation Olympus endoscope

Interventions

Olympus Elite

New generation Olympus endoscope

Intervention Type: DEVICE

Olympus Spectrum

Current generation Olympus endoscope

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Queen Alexandra Hospital

Portsmouth, , United Kingdom

Countries

United Kingdom

Other Identifiers

PHT/2015/105

Identifier Type: -

Identifier Source: org_study_id