Barrett EsophagusELITENCT03073226
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 study testing Olympus Elite and Olympus Spectrum in people with Barrett Esophagus and Polyps, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus, Polyps
- What is being tested?
- Olympus Elite and Olympus Spectrum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2016to 6 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients attending for Barrett's surveillance OR
- Patients attending for colonic polyp surveillance or screening
- Patients are willing and able to give informed consent.
Who cannot join
- Polyp syndromes (eg FAP or Lynch Syndrome)
- Known history of IBD
Trial locations and contacts
1 site in 1 country.
About this 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.
Read more
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
- Being tested
- Olympus Elite, Olympus Spectrum
- Medical subject headings
- Barrett Esophagus, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olympus EliteDevice
New generation Olympus endoscope
Olympus SpectrumDevice
Current generation Olympus endoscope
| Study group | Role | What they receive |
|---|---|---|
| Barrett's surveillance Olympus Spectrum | Experimental | Barrett's surveillance with Olympus Spectrum. Receives: Device: Olympus Spectrum |
| Barrett's Surveillance Olympus Elite | Experimental | Barrett's surveillance with Olympus ELITE. Receives: Device: Olympus Elite |
| Polyp Surveillance Olympus Spectrum | Experimental | Colonic polyp surveillance/screening with Olympus Spectrum. Receives: Device: Olympus Spectrum |
| Polyp Surveillancewith Olympus ELITE. | Experimental | Colonic polyp surveillance/screening with Olympus ELITE. Receives: Device: Olympus Elite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Difference in the sensitivity of in vivo lesion characterisation between Lucera Elite vs Lucera Spectrum as compared to final histology.
Measured: Baseline and 1 day
Secondary outcomes (3)
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.
Measured: Baseline and 1 day
Sensitivity of Dual Focus technology
Difference in sensitivity of lesion characterisation when using dual focus technology.
Measured: Baseline and 1 day
Endoscopists confidence
Difference in endoscopists' confidence scores in lesion characterisation between new and current technologies.
Measured: Baseline and 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start6 Feb 2016
- Primary completionNov 2017
- Study completion6 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073226
- Sponsor's protocol ID
- PHT/2015/105
- Acronym
- ELITE
- Status last verified
- Jun 2019
- First submitted
- 28 Feb 2017
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03073226
- Acronym / sponsor ID
- ELITE / PHT/2015/105
- Conditions
- Barrett Esophagus, Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 6 Feb 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Barrett's surveillance Olympus Spectrum | Experimental | Device: Olympus SpectrumBarrett's surveillance with Olympus Spectrum. |
| Barrett's Surveillance Olympus Elite | Experimental | Device: Olympus EliteBarrett's surveillance with Olympus ELITE. |
| Polyp Surveillance Olympus Spectrum | Experimental | Device: Olympus SpectrumColonic polyp surveillance/screening with Olympus Spectrum. |
| Polyp Surveillancewith Olympus ELITE. | Experimental | Device: Olympus EliteColonic polyp surveillance/screening with Olympus ELITE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients attending for Barrett's surveillance OR
- Patients attending for colonic polyp surveillance or screening
- Patients are willing and able to give informed consent.
Key exclusion criteria (2 listed)
- Polyp syndromes (eg FAP or Lynch Syndrome)
- Known history of IBD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olympus EliteNew generation Olympus endoscope | Device | Barrett's Surveillance Olympus Elite, Polyp Surveillancewith Olympus ELITE. |
| Olympus SpectrumCurrent generation Olympus endoscope | Device | Barrett's surveillance Olympus Spectrum, Polyp Surveillance Olympus Spectrum |
Primary outcome
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.
3 secondary outcomes
Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.
Time frame: Baseline and 1 day
Sensitivity of Dual Focus technology
Time frame: Baseline and 1 day
Endoscopists confidence
Time frame: Baseline and 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: No. No current plan
Related trials for Barrett Esophagus
RecruitingObservational study
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Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
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"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
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Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
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Impact of RFA on Esophageal Distensibility and Mucosal Impedance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olympus Elite and Olympus Spectrum in people with Barrett Esophagus and Polyps, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Baseline and 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.