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 Esophagus Clinical Trial

— ELITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073226
• Other study ID #: PHT/2015/105
• Status: Completed
• Phase: N/A
• Start date: February 6, 2016
• Est. completion date: February 6, 2018

Study information

• Verified date: June 2019
• Source: Portsmouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: February 6, 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Polyps

Intervention

Device:
• Olympus Elite
New generation Olympus endoscope
• Olympus Spectrum
Current generation Olympus endoscope

Locations

Country	Name	City	State
United Kingdom	Queen Alexandra Hospital	Portsmouth

Sponsors (1)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Difference in the sensitivity of in vivo lesion characterisation between Lucera Elite vs Lucera Spectrum as compared to final histology.	Baseline and 1 day
Secondary	Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.	Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.	Baseline and 1 day
Secondary	Sensitivity of Dual Focus technology	Difference in sensitivity of lesion characterisation when using dual focus technology.	Baseline and 1 day
Secondary	Endoscopists confidence	Difference in endoscopists' confidence scores in lesion characterisation between new and current technologies.	Baseline and 1 day