Colonic PolypEndoBrainNCT04510545
Computer Aided Diagnosis of Colorectal Polyps
An observational study of Colonic Polyp and Colorectal Cancer, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess whether computer aided technology (CAD) can help in the diagnosis of polyps found the bowel compared with visual inspection alone and therefore whether it is beneficial in helping clinicians to decide whether to remove a polyp or not. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp, Colorectal Cancer
- What is being tested?
- Endobrain, Computer Aided Diagnosis (CAD)
- How many people
- 89 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2020to 5 May 2021
- Phase
- Observational
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any patient 18 years or older scheduled for screening, surveillance, diagnostic, or therapeutic colonoscopy at King's College Hospital with diminutive rectosigmoid polyps.
Who may be able to join
- Individuals 18 years or older who are scheduled for screening, surveillance, diagnostic, or therapeutic colonoscopy at at King's College Hospital with diminutive rectosigmoid polyps.
Who cannot join
- Diminutive polyps with known histology
- Inflammatory bowel disease
- Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis)
- History of chemotherapy or radiation therapy for colorectal lesions
- Inability to undergo polypectomy (e.g. intake of anticoagulants, comorbidities, or patient refusal)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-Time Artificial Intelligence Aided Diagnosis of Colorectal Polyps During Colonoscopy: A Clinical Trial With the EndoBRAIN Technology
The purpose of this study is to assess whether computer aided technology (CAD) can help in the diagnosis of polyps found the bowel compared with visual inspection alone and therefore whether it is beneficial in helping clinicians to decide whether to remove a polyp or not. Presently, most endoscopists remove all polyps found and send them to the laboratory for testing. The number of colonoscopies is increasing, meaning that more polyps are detected and removed. This comes at a significant cost to the health service and increases the time taken to complete a colonoscopy.
Read the detailed description
Removing precancerous polyps from the bowel during a colonoscopy (camera test) is the cornerstone of colorectal cancer screening and prevents polyps developing into bowel cancer. Most polyps develop in the rectosigmoid colon (lower part of the bowel). Many polyps never grow into cancer and it can be difficult for the clinicians performing the procedure (endoscopists) to tell which ones are precancerous. This means many polyps are removed unnecessarily, with a considerable waste of resources.
A recent preliminary study indicates a novel artificial intelligence system (EndoBRAIN) for computer-aided diagnosis may be able to distinguish different types of polyps during colonoscopy and therefore help doctors decide which polyps to remove. This study aims to compare the in accuracy of artificial intelligence against the endoscopist's assessment for diagnosis of diminutive (<5mm) polyps in the lower colon.
Patients who are age 18 years or older who undergo colonoscopy for any indication at the participating clinical centres and are diagnosed with diminutive rectosigmoid polyps are eligible for study enrolment. For each detected polyp in the rectosigmoid colon, endoscopists will assess the polyp type using standard colonoscopies (cameras) and then with the use of the EndoBRAIN technology.
The polyps will be removed and sent to the laboratory for testing. The difference between clinician diagnosis and EndoBRAIN diagnosis will be compared with the laboratory findings. We hypothesize that the EndoBRAIN technology provides a superior accuracy in identifying precancerous rectosigmoid polyps, compared to endoscopist's own prediction with a standard colonoscope.
If the trial confirms the superior accuracy of the EndoBRAIN system, polyps classified as non-cancerous with the EndoBRAIN system no longer need to be removed, meaning a large gain for patients and society, due to significantly less polypectomies and pathology reviews.
- Conditions
- Colonic Polyp, Colorectal Cancer
- Being tested
- Endobrain, Computer Aided Diagnosis (CAD)
- Medical subject headings
- Colonic Polyps, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobrain, Computer Aided Diagnosis (CAD)Diagnostic test
Artificial intelligence
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | All patients will undergo CAD of any diminutive polyps found in the rectosigmoid on colonoscopy Receives: Diagnostic Test: Endobrain, Computer Aided Diagnosis (CAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
True positive adenoma detection rate
True positive adenoma detection rate with visual inspection versus true positive adenoma detection rate with visual inspection plus CAD
Measured: 6 months
Secondary outcomes (7)
True negative adenoma detection rate
True negative adenoma detection rate with visual inspection versus true negative adenoma detection rate with visual inspection plus CAD
Measured: 6 months
To estimate the sensitivity, specificity, of visual inspection and the use of the EndoBRAIN CAD technology
To estimate the sensitivity, specificity, of visual inspection and the use of the EndoBRAIN CAD technology
Measured: 6 months
To estimate the positive predictive value [PPV], and NPV of the combination of visual inspection and the use of the EndoBRAIN CAD technology
To estimate the positive predictive value [PPV], and NPV of the combination of visual inspection and the use of the EndoBRAIN CAD technology
Measured: 6 months
To estimate the percentage of diminutive colorectal polyps from which endocytoscopic images can be successfully captured (acquisition rate).
To estimate the percentage of diminutive colorectal polyps from which endocytoscopic images can be successfully captured (acquisition rate).
Measured: 6 months
To estimate the rate of high-confidence diagnosis with EndoBRAIN as compared to visual polyp inspection alone.
To estimate the rate of high-confidence diagnosis with EndoBRAIN as compared to visual polyp inspection alone.
Measured: 6 months
Time of colonoscopy
Time of colonoscopy to be recorded.
Measured: during procedure
Complications
complications to be recorded.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Jun 2020
- Primary completion5 May 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510545
- Sponsor's protocol ID
- 260047
- Acronym
- EndoBrain
- Status last verified
- Jan 2022
- First submitted
- 24 Sep 2019
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will be kept within the research team.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Artificial Intelligence Aided Diagnosis of Colorectal Polyps During Colonoscopy: A Clinical Trial With the EndoBRAIN Technology
- ClinicalTrials.gov ID
- NCT04510545
- Acronym / sponsor ID
- EndoBrain / 260047
- Conditions
- Colonic Polyp, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 12 Aug 2020 (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.
The purpose of this study is to assess whether computer aided technology (CAD) can help in the diagnosis of polyps found the bowel compared with visual inspection alone and therefore whether it is beneficial in helping clinicians to decide whether to remove a polyp or not. Presently, most endoscopists remove all polyps found and send them to the laboratory for testing. The number of colonoscopies is increasing, meaning that more polyps are detected and removed. This comes at a significant cost to the health service and increases the time taken to complete a colonoscopy.
Detailed description
Removing precancerous polyps from the bowel during a colonoscopy (camera test) is the cornerstone of colorectal cancer screening and prevents polyps developing into bowel cancer. Most polyps develop in the rectosigmoid colon (lower part of the bowel). Many polyps never grow into cancer and it can be difficult for the clinicians performing the procedure (endoscopists) to tell which ones are precancerous. This means many polyps are removed unnecessarily, with a considerable waste of resources.
A recent preliminary study indicates a novel artificial intelligence system (EndoBRAIN) for computer-aided diagnosis may be able to distinguish different types of polyps during colonoscopy and therefore help doctors decide which polyps to remove. This study aims to compare the in accuracy of artificial intelligence against the endoscopist's assessment for diagnosis of diminutive (<5mm) polyps in the lower colon.
Patients who are age 18 years or older who undergo colonoscopy for any indication at the participating clinical centres and are diagnosed with diminutive rectosigmoid polyps are eligible for study enrolment. For each detected polyp in the rectosigmoid colon, endoscopists will assess the polyp type using standard colonoscopies (cameras) and then with the use of the EndoBRAIN technology.
The polyps will be removed and sent to the laboratory for testing. The difference between clinician diagnosis and EndoBRAIN diagnosis will be compared with the laboratory findings. We hypothesize that the EndoBRAIN technology provides a superior accuracy in identifying precancerous rectosigmoid polyps, compared to endoscopist's own prediction with a standard colonoscope.
If the trial confirms the superior accuracy of the EndoBRAIN system, polyps classified as non-cancerous with the EndoBRAIN system no longer need to be removed, meaning a large gain for patients and society, due to significantly less polypectomies and pathology reviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Diagnostic Test: Endobrain, Computer Aided Diagnosis (CAD)All patients will undergo CAD of any diminutive polyps found in the rectosigmoid on colonoscopy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient 18 years or older scheduled for screening, surveillance, diagnostic, or therapeutic colonoscopy at King's College Hospital with diminutive rectosigmoid polyps.
Key inclusion criteria (1 listed)
- Individuals 18 years or older who are scheduled for screening, surveillance, diagnostic, or therapeutic colonoscopy at at King's College Hospital with diminutive rectosigmoid polyps.
Key exclusion criteria (6 listed)
- Diminutive polyps with known histology
- Inflammatory bowel disease
- Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis)
- History of chemotherapy or radiation therapy for colorectal lesions
- Inability to undergo polypectomy (e.g. intake of anticoagulants, comorbidities, or patient refusal)
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 |
|---|---|---|
| Endobrain, Computer Aided Diagnosis (CAD)Artificial intelligence | Diagnostic test | Treatment Group |
Primary outcome
True positive adenoma detection rate
Time frame: 6 months
True positive adenoma detection rate with visual inspection versus true positive adenoma detection rate with visual inspection plus CAD
7 secondary outcomes
True negative adenoma detection rate
Time frame: 6 months
To estimate the sensitivity, specificity, of visual inspection and the use of the EndoBRAIN CAD technology
Time frame: 6 months
To estimate the positive predictive value [PPV], and NPV of the combination of visual inspection and the use of the EndoBRAIN CAD technology
Time frame: 6 months
To estimate the percentage of diminutive colorectal polyps from which endocytoscopic images can be successfully captured (acquisition rate).
Time frame: 6 months
To estimate the rate of high-confidence diagnosis with EndoBRAIN as compared to visual polyp inspection alone.
Time frame: 6 months
Time of colonoscopy
Time frame: during procedure
Complications
Time frame: 6 months
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 31 Jan 2022.
- Individual participant dataSharing planned: No. The IPD will be kept within the research team.
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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?
An observational study of Colonic Polyp and Colorectal Cancer, run by King's College Hospital 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 1 inclusion and 6 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 31 Jan 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. 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?
True positive adenoma detection rate (time frame: 6 months). 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 31 Jan 2022.