GastritisNCT02385045
i-Scan for the Detection of Helicobacter Pylori
A study testing i-scan and narrow band imaging in people with Gastritis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study aims to assess whether iScan, an intra-endoscopic imaging technique is an accurate and reliable tool in detecting and characterising Helicobacter pylori (H pylori) and comparing this to standard endoscopic imaging with white light endoscopy (WLE), narrow band imaging (NBI) and histology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastritis
- What is being tested?
- i-scan and narrow band imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All patients attending for a routine diagnostic endoscopic procedure at St Mary's Hospital NHS Trust for dyspepsia and abdominal pain
Who cannot join
- Patients attending for a therapeutic endoscopic procedure e.g. variceal banding, stent insertion, balloon dilatation.
- Patients with a known diagnosis e.g. upper gastrointestinal cancer
- Patients previously treated with HP eradication therapy
- Patients who had taken PPI, H2 receptor antagonists and antibiotics within 4 weeks
- Patients with acute gastrointestinal bleeding
- Patients who'd had previous gastric surgery
Show all 10Show fewer
- Patients with chronic liver disease
- Patients with abnormal coagulation or any other contra-indication to use of standard biopsy in routine diagnostic endoscopic procedures
- Patients who are unable or unwilling to give informed consent
- Patients under the age of 18 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London
London, Greater London, W2 1NY
About this study
This study aims to assess whether iScan, an intra-endoscopic imaging technique is an accurate and reliable tool in detecting and characterising Helicobacter pylori (H pylori) and comparing this to standard endoscopic imaging with white light endoscopy (WLE), narrow band imaging (NBI) and histology.
Read the detailed description
The ultimate goal of endoscopy will be the 'optical biopsy' i.e. forgoing the need to take histological samples to make a diagnosis in order to reduce complication rates, cost and time. There are a number of imaging techniques which promise to improve our diagnostic rates for pathology, but there have been few comparative studies.
This is randomized controlled parallel trial in a 1:1 ratio with examination of the upper gastrointestinal tract with WLE followed by either NBI or iscan.
(Note: Prior to commencement of the study, technical issues and operational changes in our organisation forced the removal of the Pentax 'i-scan' endoscopes. Recruitment to this arm was anticipated, but was ultimately not possible.)
Patients attending the department for routine examinations for dyspepsia and abdominal pain will be randomised into 2 study arms (1WLE and NBI, and the other - WLE and iscan).
The investigator carrying out the procedure will be blinded to the indication for the procedure until a full examination with both white light endoscopy and either NBI or iscan has been used as this could lead to bias. They will determine if H pylori is present, and if so the severity of infection with WLE and again with either NBI or iscan depending on their study arm. Histopathological confirmation of H pylori and an assessment to the degree of infection will be assessed with samples taken using the updated Sydney system (5 gastric samples from different parts of the stomach).
The endoscopists reviewing the images will be blinded to all patient information and indications throughout the study period. Questionnaires will then be given to the endoscopists to determine what endoscopic features led them to their diagnosis.
- Conditions
- Gastritis
- Being tested
- i-scan, narrow band imaging
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-scanDevice
i-scan function is located on the head of the Pentax endoscopes
narrow band imagingDevice
narrow band imaging function is located on the head of Olympus endoscopes
| Study group | Role | What they receive |
|---|---|---|
| Narrow band imaging | Placebo comparator | Narrow band imaging function (Olympus endoscopes) Receives: Device: narrow band imaging |
| i-scan imaging | Experimental | i-scan imaging (Pentax endoscopes) Receives: Device: i-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Diagnosis of Helicobacter Pylori Using Imaging Modality
The endoscopic assessment of the presence of H pylori using standard endoscopy plus NBI will be compared to histological assessment. Inter-observer variability of assessment of the presence of H pylori will be compared between endoscopic imaging techniques
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastritisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian Teare, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385045
- Sponsor's protocol ID
- 14SM2185
- Status last verified
- May 2022
- First submitted
- 5 Mar 2015
- Last updated
- 9 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Glover B, Teare J, Patel N. Assessment of Helicobacter pylori status by examination of gastric mucosal patterns: diagnostic accuracy of white-light endoscopy and narrow-band imaging. BMJ Open Gastroenterol. 2021 Aug;8(1):e000608. doi: 10.1136/bmjgast-2021-000608.
PubMed 34353822
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- i-Scan for the Detection of Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT02385045
- Acronym / sponsor ID
- 14SM2185
- Conditions
- Gastritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Posted 9 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess whether iScan, an intra-endoscopic imaging technique is an accurate and reliable tool in detecting and characterising Helicobacter pylori (H pylori) and comparing this to standard endoscopic imaging with white light endoscopy (WLE), narrow band imaging (NBI) and histology.
Detailed description
The ultimate goal of endoscopy will be the 'optical biopsy' i.e. forgoing the need to take histological samples to make a diagnosis in order to reduce complication rates, cost and time. There are a number of imaging techniques which promise to improve our diagnostic rates for pathology, but there have been few comparative studies.
This is randomized controlled parallel trial in a 1:1 ratio with examination of the upper gastrointestinal tract with WLE followed by either NBI or iscan.
(Note: Prior to commencement of the study, technical issues and operational changes in our organisation forced the removal of the Pentax 'i-scan' endoscopes. Recruitment to this arm was anticipated, but was ultimately not possible.)
Patients attending the department for routine examinations for dyspepsia and abdominal pain will be randomised into 2 study arms (1WLE and NBI, and the other - WLE and iscan).
The investigator carrying out the procedure will be blinded to the indication for the procedure until a full examination with both white light endoscopy and either NBI or iscan has been used as this could lead to bias. They will determine if H pylori is present, and if so the severity of infection with WLE and again with either NBI or iscan depending on their study arm. Histopathological confirmation of H pylori and an assessment to the degree of infection will be assessed with samples taken using the updated Sydney system (5 gastric samples from different parts of the stomach).
The endoscopists reviewing the images will be blinded to all patient information and indications throughout the study period. Questionnaires will then be given to the endoscopists to determine what endoscopic features led them to their diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow band imaging | Placebo comparator | Device: narrow band imagingNarrow band imaging function (Olympus endoscopes) |
| i-scan imaging | Experimental | Device: i-scani-scan imaging (Pentax endoscopes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients attending for a routine diagnostic endoscopic procedure at St Mary's Hospital NHS Trust for dyspepsia and abdominal pain
Key exclusion criteria (10 listed)
- Patients attending for a therapeutic endoscopic procedure e.g. variceal banding, stent insertion, balloon dilatation.
- Patients with a known diagnosis e.g. upper gastrointestinal cancer
- Patients previously treated with HP eradication therapy
- Patients who had taken PPI, H2 receptor antagonists and antibiotics within 4 weeks
- Patients with acute gastrointestinal bleeding
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 |
|---|---|---|
| i-scani-scan function is located on the head of the Pentax endoscopes | Device | i-scan imaging |
| narrow band imagingnarrow band imaging function is located on the head of Olympus endoscopes | Device | Narrow band imaging |
Primary outcome
Successful Diagnosis of Helicobacter Pylori Using Imaging Modality
Time frame: 1 year
The endoscopic assessment of the presence of H pylori using standard endoscopy plus NBI will be compared to histological assessment. Inter-observer variability of assessment of the presence of H pylori will be compared between endoscopic imaging techniques
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34353822Glover B, Teare J, Patel N. Assessment of Helicobacter pylori status by examination of gastric mucosal patterns: diagnostic accuracy of white-light endoscopy and narrow-band imaging. BMJ Open Gastroenterol. 2021 Aug;8(1):e000608. doi: 10.1136/bmjgast-2021-000608.
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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.
Julian Teare principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-scan and narrow band imaging in people with Gastritis, run by Imperial College London 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 1 inclusion and 10 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 9 May 2022. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Successful Diagnosis of Helicobacter Pylori Using Imaging Modality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02385045, which also lists 1 linked publication.
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 9 May 2022.