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 (ELITE)
Primary Purpose
Barrett Esophagus, Polyps
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Olympus Elite
Olympus Spectrum
Sponsored by
About this trial
This is an interventional diagnostic trial for Barrett Esophagus
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
Sites / Locations
- Queen Alexandra Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Barrett's surveillance Olympus Spectrum
Barrett's Surveillance Olympus Elite
Polyp Surveillance Olympus Spectrum
Polyp Surveillancewith Olympus ELITE.
Arm Description
Barrett's surveillance with Olympus Spectrum.
Barrett's surveillance with Olympus ELITE.
Colonic polyp surveillance/screening with Olympus Spectrum.
Colonic polyp surveillance/screening with Olympus ELITE.
Outcomes
Primary Outcome Measures
Sensitivity
Difference in the sensitivity of in vivo lesion characterisation between Lucera Elite vs Lucera Spectrum as compared to final histology.
Secondary Outcome Measures
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.
Sensitivity of Dual Focus technology
Difference in sensitivity of lesion characterisation when using dual focus technology.
Endoscopists confidence
Difference in endoscopists' confidence scores in lesion characterisation between new and current technologies.
Full Information
NCT ID
NCT03073226
First Posted
February 28, 2017
Last Updated
June 25, 2019
Sponsor
Portsmouth Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03073226
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 6, 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
February 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Portsmouth Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus, Polyps
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
232 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Barrett's surveillance Olympus Spectrum
Arm Type
Experimental
Arm Description
Barrett's surveillance with Olympus Spectrum.
Arm Title
Barrett's Surveillance Olympus Elite
Arm Type
Experimental
Arm Description
Barrett's surveillance with Olympus ELITE.
Arm Title
Polyp Surveillance Olympus Spectrum
Arm Type
Experimental
Arm Description
Colonic polyp surveillance/screening with Olympus Spectrum.
Arm Title
Polyp Surveillancewith Olympus ELITE.
Arm Type
Experimental
Arm Description
Colonic polyp surveillance/screening with Olympus ELITE.
Intervention Type
Device
Intervention Name(s)
Olympus Elite
Intervention Description
New generation Olympus endoscope
Intervention Type
Device
Intervention Name(s)
Olympus Spectrum
Intervention Description
Current generation Olympus endoscope
Primary Outcome Measure Information:
Title
Sensitivity
Description
Difference in the sensitivity of in vivo lesion characterisation between Lucera Elite vs Lucera Spectrum as compared to final histology.
Time Frame
Baseline and 1 day
Secondary Outcome Measure Information:
Title
Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.
Description
Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.
Time Frame
Baseline and 1 day
Title
Sensitivity of Dual Focus technology
Description
Difference in sensitivity of lesion characterisation when using dual focus technology.
Time Frame
Baseline and 1 day
Title
Endoscopists confidence
Description
Difference in endoscopists' confidence scores in lesion characterisation between new and current technologies.
Time Frame
Baseline and 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Queen Alexandra Hospital
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No current plan
Learn more about this trial
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
We'll reach out to this number within 24 hrs