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COLO-DETECT: Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy?

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ClinicalTrials.gov Identifier: NCT04723758
Recruitment Status : Not yet recruiting
First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Collaborators:
North Wales Organisation for Randomised Trials in Health
Newcastle University
Medtronic
Information provided by (Responsible Party):
South Tyneside and Sunderland NHS Foundation Trust

Brief Summary:
COLO-DETECT is a clinical trial to evaluate whether an Artificial Intelligence device ("GI Genius", manufactured by Medtronic) can identify more polyps (pre-cancerous growths of the bowel lining) during colonoscopy (large bowel camera test) than during colonoscopy without it.

Condition or disease Intervention/treatment Phase
Colonic Polyp Colorectal Polyp Colorectal Adenoma Colorectal Adenomatous Polyp Colorectal SSA Sessile Serrated Adenoma Sessile Colonic Polyp Device: GI Genius-assisted diagnostic colonoscopy Diagnostic Test: Diagnostic Colonoscopy Not Applicable

Detailed Description:

Colorectal cancer is common, affecting 1 in 15 men and 1 in 18 women in the UK in their lifetime. Many colorectal cancers develop from polyps via the adenoma-carcinoma sequence: there is a pre-cancerous stage (adenoma) during which it is possible to remove the polyp and therefore prevent it from progressing to colorectal cancer. The gold standard tool for doing this is colonoscopy. However, colonoscopy does not pick up all polyps, particularly flat polyps.

Missed polyps can result in colorectal cancer, so it is imperative to detect and remove as many polyps as possible. Many different interventions have been introduced to improve polyp detection, the most recent of which is artificial intelligence devices. GI Genius is an artificial intelligence device which integrates with existing colonoscopy equipment and analyses the video feed from the colonoscope camera in real time. Any areas that may represent an abnormality are then highlighted (without any lag) within a green box, alerting the colonoscopist to its presence. The potential abnormality can then be assessed more closely by the colonoscopist to decide whether it needs to be removed or not.

COLO-DETECT is a 2-arm, prospective, randomised controlled trial to assess whether GI Genius is able to detect more polyps (specifically, adenomas) during colonoscopy than standard colonoscopy without GI Genius. The primary outcome will be the mean number of adenomas per procedure (MAP) and the key secondary outcome will be the proportion of colonoscopies in which one or more adenomas is detected (Adenoma Detection Rate - ADR). These are both important quality markers for colonoscopy; the study will be powered to detect a clinically meaningful difference in ADR, which will by default detect a meaningful difference in MAP as the sample size required for ADR is larger.

In addition to measuring the effect of GI Genius on polyp detection, COLO-DETECT will provide a health economics analysis concerning the use of GI Genius, perform long-term passive follow-up to examine for future outcomes related to colorectal polyps and colorectal cancer, and perform additional nested studies (subject to ethical approval) that examine the effect upon users (for example through a visual scanning study) and their experience of using the GI Genius.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2032 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The patient and colonoscopist (care provider) cannot be blinded to the allocation. The investigator and statistician will remain blinded to the allocation until analysis has been conducted.
Primary Purpose: Diagnostic
Official Title: COLO-DETECT: A Randomised Controlled Trial of Lesion Detection at Colonoscopy Using the GI Genius Artificial Intelligence Platform
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: GI Genius-assisted colonoscopy (GGC)
In the GGC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure, except that at some point prior to commencing withdrawal of the colonoscope, a member of the endoscopy staff will turn on the GI Genius machine. This will remain operational from the time it is switched on until the end of the procedure.
Device: GI Genius-assisted diagnostic colonoscopy
Participants will undergo diagnostic colonoscopy, which will be identical to the normal standard of care at the unit where they are undergoing their procedure, except that GI Genius will be turned on during the procedure.

Active Comparator: Standard Colonoscopy (SC)
In the SC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure.
Diagnostic Test: Diagnostic Colonoscopy
Diagnostic colonoscopy will be performed as per the standard of care for the unit where the patient is having their procedure.




Primary Outcome Measures :
  1. Number of adenomas per participant detected at colonoscopy as indicated by the Mean Number of Adenomas per Procedure (MAP) [ Time Frame: The number of adenomas detected in each procedure will be counted at 14 days post-procedure ]
    The number of adenomas identified during each colonoscopy will be summed and divided by the total number of colonoscopies performed. MAP is usually expressed as a number to one decimal place (e.g. 1.2).


Secondary Outcome Measures :
  1. Proportion of participants in whom at least one adenoma is detected at colonoscopy, as indicated by the Adenoma Detection Rate (ADR) [ Time Frame: The presence or absence of any adenomas will be determined at 14 days post-procedure ]
    Whether or not at least one adenoma is detected at colonoscopy will be determined for each participant. The number of colonoscopies where one or more adenomas is identified will be divided by the total number of colonoscopies to give the ADR. ADR is usually expressed as a percentage.

  2. Number of adenomas per participant detected at colonoscopy in the 'screening' participant population, as indicated by MAP for that participant population. [ Time Frame: The number of adenomas detected will be counted at 14 days post-procedure ]
    The number of adenomas identified during each colonoscopy within the 'screening' participant population will be summed and divided by the total number of colonoscopies in that participant population. The MAP for the 'screening' participant population within each study arm will be compared

  3. Number of adenomas per participant detected at colonoscopy in the 'symptomatic' participant population, as indicated by MAP for that participant population [ Time Frame: The number of adenomas detected will be counted at 14 days post-procedure ]
    The number of adenomas identified during each colonoscopy within the 'symptomatic' participant population will be summed and divided by the total number of colonoscopies in that participant population to calculate MAP. The MAP for the 'symptomatic' participant population within each study arm will be compared

  4. Proportion of participants in the 'screening' participant population in whom at least one adenoma is detected at colonoscopy, as indicated by ADR for that participant population [ Time Frame: The presence or absence of any adenomas will be determined at 14 days post-procedure ]
    Whether or not at least one adenoma is detected at colonoscopy will be determined for each participant within the 'screening' participant population. The number of colonoscopies where one or more adenomas is identified will be divided by the total number of colonoscopies in that participant population to calculate ADR. The ADR for the 'screening' participant population within each study arm will be compared

  5. Proportion of participants in the 'symptomatic' participant population in whom at least one adenoma is detected at colonoscopy, as indicated by ADR for that participant population [ Time Frame: The presence or absence of any adenomas will be determined at 14 days post-procedure ]
    Whether or not at least one adenoma is detected at colonoscopy will be determined for each participant within the 'symptomatic' participant population. The number of colonoscopies where one or more adenomas is identified will be divided by the total number of colonoscopies in that participant population to calculate ADR. The ADR for the 'symptomatic' participant population within each study arm will be compared

  6. Number of polyps per participant detected at colonoscopy, as indicated by the Mean number of Polyps per Procedure (MPP) [ Time Frame: Total number of polyps detected at colonoscopy will be determined at the end of the procedure ]
    The total number of polyps detected during each colonoscopy will be summed, and divided by the total number of colonoscopies, to calculate MPP. MPP is usually expressed as a number to one decimal place.

  7. Number of polyps per participant detected at colonoscopy in the 'screening' participant population, as indicated by the Mean number of Polyps per Procedure (MPP) [ Time Frame: Total number of polyps detected at colonoscopy will be determined at the end of the procedure ]
    The total number of polyps detected during colonoscopy for each participant within the 'screening' participant population. will be summed, and divided by the total number of colonoscopies in that participant population, to calculate MPP. MPP is usually expressed as a number to one decimal place.

  8. Number of polyps per participant detected at colonoscopy in the 'symptomatic' participant population,as indicated by the Mean number of Polyps per Procedure (MPP) [ Time Frame: Total number of polyps detected at colonoscopy will be determined at the end of the procedure ]
    The total number of polyps detected during colonoscopy for each participant within the 'symptomatic' participant population will be summed, and divided by the total number of colonoscopies in that participant population, to calculate MPP. MPP is usually expressed as a number to one decimal place.

  9. Proportion of participants in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR) [ Time Frame: The presence or absence of at least one polyp will be determined at the end of the procedure ]
    Whether or not at least one polyp is detected at colonoscopy will be determined for each participant. The number of colonoscopies where one or more polyps is detected will be divided by the total number of colonoscopies in that participant population to calculate PDR, which is normally expressed as a percentage.

  10. Proportion of participants in the 'screening' participant population in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR) [ Time Frame: The presence or absence of at least one polyp will be determined at the end of the procedure ]
    Whether or not at least one polyp is detected at colonoscopy will be determined for each participant within the 'screening' participant population. The number of colonoscopies where one or more polyps is identified will be divided by the total number of colonoscopies in that participant population to calculate PDR, which is normally expressed as a percentage.

  11. Proportion of participants in the 'symptomatic' participant population in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR) [ Time Frame: The presence or absence of at least one polyp will be determined at the end of the procedure ]
    Whether or not at least one polyp is detected at colonoscopy will be determined for each participant within the 'symptomatic' participant population. The number of colonoscopies where one or more polyps is identified will be divided by the total number of colonoscopies in that participant population to calculate PDR, which is normally expressed as a percentage.

  12. Polyp characteristics and location [ Time Frame: Assessed over duration of colonoscopy procedure and at time of 14 day post-colonoscopy review (once histology is known) ]
    The location, size, and morphology of the polyps identified (and histology if retrieved) in each study arm will be compared. This will also be analysed for both the screening and symptomatic participant populations in each study arm.

  13. Sessile Serrated Polyp (SSP) detection rate [ Time Frame: SSP Detection Rate will be calculated at the time of study completion, expected to be 18 months ]
    The number of colonoscopies in each study arm in which one or more SSPs is identified, divided by the total number of colonoscopies in each arm. This will also be analysed for both the screening and symptomatic participant populations in each study arm.

  14. Colorectal Cancer (CRC) detection rate [ Time Frame: CRC Detection Rate will be calculated at the time of study completion, expected to be 18 months ]
    The number of CRCs detected in each study arm divided by the total number of colonoscopies in each arm. This will include polyps removed and later found to cancerous on histology and lesions felt to be cancerous at the time of colonoscopy. This will also be analysed for both the screening and symptomatic participant populations in each study arm.

  15. Advanced Adenoma (AA) detection rate [ Time Frame: AA Detection Rate will be calculated at the time of study completion, expected to be 18 months ]
    The number of AAs detected in each study arm divided by the total number of colonoscopies in each arm. This will also be analysed for both the screening and symptomatic participant populations in each study arm.

  16. Caecal Intubation Rate [ Time Frame: Caecal Intubation Rate will be calculated at the time of study completion, expected to be 18 months ]
    Caecal intubation rate (the proportion of colonoscopies in which the colonoscope reaches the furthest extent of the colon) will be compared between the study arms to assess for non-inferiority

  17. Insertion time to caecum [ Time Frame: Measured during colonoscopy within the study. ]
    Insertion time to caecum (time taken to reach the furthest point of the large bowel) will be compared between the study arms to assess for non-inferiority

  18. Total Procedure Time [ Time Frame: Measured during colonoscopy within the study. ]
    Total time required to perform the colonoscopy will be compared between the study arms to assess for non-inferiority

  19. Total Withdrawal Time (in absence of polyps) [ Time Frame: Measured during colonoscopy within the study. ]
    Total withdrawal time (time taken to remove the colonoscope from the furthest point of the colon) in the absence of any polyps will be compared between the study arms to assess for non-inferiority

  20. Colonoscopist-assessed patient comfort score [ Time Frame: Measured during colonoscopy within the study. ]
    Colonoscopist-assessed patient comfort scores will be compared between the study arms to assess for non-inferiority

  21. Nurse-assessed patient comfort score [ Time Frame: Measured during colonoscopy within the study. ]
    Nurse-assessed patient comfort scores will be compared between the study arms to assess for non-inferiority

  22. Patient-Reported Experience [ Time Frame: Assessed one day after the procedure ]
    A validated Patient-Reported Experience Measure (Newcastle ENDOPREM) will be used to compare patient experience of colonoscopy between study arms

  23. Patient-Reported Health-Related Quality of Life [ Time Frame: Assessed one day after the procedure ]
    The EuroQoL EQ-5D-5L (validated quality of life questionnaire) will be used to compare patient-reported health-related quality of life, between study arms

  24. Projected future endoscopy workload [ Time Frame: Assessed immediately after colonoscopy ]
    The need for further colonoscopy for each participant is determined by the findings at the index colonoscopy, according to national guidelines on polyp surveillance. This may differ between study arms if more polyps are identified in one arm.

  25. MAP according to BCSP status of colonoscopist [ Time Frame: At the time of 14-day review ]
    Some colonoscopists partake in the national Bowel Cancer Screening Programme (BCSP) and some do not. MAP will be analysed by colonoscopist status within each study arm.

  26. ADR according to BCSP status of colonoscopist [ Time Frame: At the time of 14-day review ]
    Some colonoscopists partake in the national Bowel Cancer Screening Programme (BCSP) and some do not. ADR will be analysed by colonoscopist status within each study arm.

  27. Change in number of adenomas detected per colonoscopy, for each colonoscopist, over the course of the study, as indicated by MAP [ Time Frame: At the time of 14-day review ]
    MAP for the first 20 percent of participants will be compared to MAP for the last 20 percent of participants scoped by each participating colonoscopist, to assess for change over the course of the study.

  28. Change in proportion of participants in whom at least one adenoma is detected during colonoscopy, for each colonoscopist, over the course of the study, as indicated by ADR. [ Time Frame: At the time of 14-day review ]
    ADR for the first 20 percent of participants will be compared to ADR for the last 20 percent of participants scoped by each participating colonoscopist, to assess for change over the course of the study.

  29. Change in number of adenomas detected per participant, for each participating colonoscopist, from pre-study to intra-study (SC arm only) [ Time Frame: At the time of 14-day review ]
    MAP may vary from baseline, even in the control arm due to a contamination or learning effect; comparing baseline values to those during the study assesses for this effect.

  30. Proportion of participants in whom at least one adenoma is detected during colonoscopy, for each participating colonoscopist, from pre-study to intra-study (SC arm only) [ Time Frame: At the time of 14-day review ]
    ADR may vary from baseline, even in the control arm due to a contamination or learning effect; comparing baseline values to those during the study assesses for this effect.


Other Outcome Measures:
  1. Cost-effectiveness of GGC versus SC [ Time Frame: Costs associated with each participant's procedure and care will be calculated at time of 14-day review ]
    Equipment, staff, histology, unplanned admission, and other related costs will be calculated and used to determine cost-effectiveness of GGC versus SC.

  2. Number of adenomas per participant detected at colonoscopy, amongst colonoscopists not participating in the study, as indicated by MAP [ Time Frame: At time of 14-day review ]
    MAP values over the duration of the study, for colonoscopists not participating in the study but performing colonoscopy at study sites, will assist with baseline comparisons. These data are reported by endoscopy units as part of the normal endoscopy quality assurance programme.

  3. Proportion of participants in whom at least one adenoma is detected at colonoscopy, by colonoscopists not participating in the study, as indicated by ADR [ Time Frame: At time of 14-day review ]
    ADR values over the duration of the study, for colonoscopists not participating in the study but performing colonoscopy at study sites, will assist with baseline comparisons. These data are reported by endoscopy units as part of the normal endoscopy quality assurance programme.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to give informed consent
  • Patients attending for colonoscopy

    • Through standard National Health Service (NHS) care (most commonly due to iron deficiency anaemia, altered bowel habit, weight loss, rectal bleeding, positive FIT (faecal immunohistochemical test) based on symptoms, those referred on basis of family history, abnormal cross- sectional imaging, polyp surveillance or post CRC surveillance)
    • Through Bowel Cancer Screening Programme (FIT positive, surveillance)
  • Colonoscopy to be performed by colonoscopist trained to perform GGC as part of the study

Exclusion Criteria:

  • Absolute contraindications to colonoscopy
  • Patients lacking capacity to give informed consent
  • Confirmed or expected pregnancy
  • Established or suspected large bowel obstruction or pseudo-obstruction
  • Known presence of colorectal cancer or polyposis syndromes
  • Known colonic strictures (meaning that the colonoscopy maybe incomplete)
  • Known active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
  • Inflammatory Bowel Disease (IBD) surveillance procedures
  • Patients who are on clopidogrel, warfarin, or other antiplatelet agents or anticoagulants who have not stopped this for the procedure (as polyps cannot be removed and thus histology cannot be confirmed)
  • Patients who are attending for a planned therapeutic procedure or assessment of a known lesion
  • Patients referred with polyps identified on Bowel Scope procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723758


Contacts
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Contact: Alexander Seager, MSc, MBChB 01914041000 ext 2899 alexander.seager@nhs.net
Contact: Amy Burns 01914041000 amy.burns@stft.nhs.uk

Locations
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United Kingdom
North Tees and Hartlepool NHS Foundation Trust
Hartlepool, County Durham, United Kingdom, TS24 9AH
Contact: John Jacob       john.jacob2@nhs.net   
University Hospitals of Morecambe Bay NHS Foundation Trust
Kendal, Cumbria, United Kingdom, LA9 7RG
Contact: Andrew Higham       andrew.higham@mbht.nhs.uk   
Northumbria Healthcare NHS Foundatin Trust
North Shields, North Tyneside, United Kingdom, NE29 8NH
Contact: Tom Lee       tom.lee@nhct.nhs.uk   
Kettering General Hospital NHS Foundation Trust
Kettering, Northamptonshire, United Kingdom, NN16 8UZ
Contact: Ajay Verma       ajay.verma@nhs.net   
South Tees Hospitals NHS Foundation Trust
Middlesbrough, Teesside, United Kingdom
Contact: John Greenaway       johngreenaway@nhs.net   
South Tyneside and Sunderland NHS Foundation Trust
Sunderland, Tyne And Wear, United Kingdom, SR4 7TP
Contact: Laura Neilson       laura.neilson@stft.nhs.uk   
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Contact: Aravinth Murugananthan       a.murugananthan@nhs.net   
Bolton NHS Foundation Trust
Bolton, United Kingdom, BL4 0JR
Contact: Reza Zadeh       reza.zadeh@boltonft.nhs.uk   
Sponsors and Collaborators
South Tyneside and Sunderland NHS Foundation Trust
North Wales Organisation for Randomised Trials in Health
Newcastle University
Medtronic
Investigators
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Study Director: Colin J Rees, MBBS Newcastle University, South Tyneside and Sunderland NHS Foundation Trust
Additional Information:
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Responsible Party: South Tyneside and Sunderland NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04723758    
Other Study ID Numbers: COLO-DETECT
286426 ( Other Identifier: IRAS )
21-WS-003 ( Other Identifier: REC Reference )
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by South Tyneside and Sunderland NHS Foundation Trust:
Diagnostic Colonoscopy
Artificial Intelligence
Computer-Aided Detection
Additional relevant MeSH terms:
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Adenoma
Adenomatous Polyps
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Polyps