Clinical trial NCT04723758: COLO-DETECT: Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy?
Official title: COLO-DETECT: A Randomised Controlled Trial of Lesion Detection at Colonoscopy Using the GI Genius Artificial Intelligence Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyp
Colorectal Polyp
Colorectal Adenoma
Colorectal Adenomatous Polyp
Colorectal SSA
Sessile Serrated Adenoma
Sessile Colonic Polyp
Keywords: Diagnostic Colonoscopy
Artificial Intelligence
Computer-Aided Detection
Lead sponsor: South Tyneside and Sunderland NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: North Wales Organisation for Randomised Trials in Health
name: Newcastle University
name: Medtronic
First posted: 2021-01-26
Enrollment: 2032
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of adenomas per participant detected at colonoscopy as indicated by the Mean Number of Adenomas per Procedure (MAP)
timeFrame: The number of adenomas detected in each procedure will be counted at 14 days post-procedure
Secondary outcomes:
measure: Proportion of participants in whom at least one adenoma is detected at colonoscopy, as indicated by the Adenoma Detection Rate (ADR)
timeFrame: The presence or absence of any adenomas will be determined at 14 days post-procedure
measure: Number of adenomas per participant detected at colonoscopy in the 'screening' participant population, as indicated by MAP for that participant population.
timeFrame: The number of adenomas detected will be counted at 14 days post-procedure
measure: Number of adenomas per participant detected at colonoscopy in the 'symptomatic' participant population, as indicated by MAP for that participant population
timeFrame: The number of adenomas detected will be counted at 14 days post-procedure
measure: 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
timeFrame: The presence or absence of any adenomas will be determined at 14 days post-procedure
measure: 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
timeFrame: The presence or absence of any adenomas will be determined at 14 days post-procedure
measure: Number of polyps per participant detected at colonoscopy, as indicated by the Mean number of Polyps per Procedure (MPP)
timeFrame: Total number of polyps detected at colonoscopy will be determined at the end of the procedure
measure: Number of polyps per participant detected at colonoscopy in the 'screening' participant population, as indicated by the Mean number of Polyps per Procedure (MPP)
timeFrame: Total number of polyps detected at colonoscopy will be determined at the end of the procedure
measure: Number of polyps per participant detected at colonoscopy in the 'symptomatic' participant population,as indicated by the Mean number of Polyps per Procedure (MPP)
timeFrame: Total number of polyps detected at colonoscopy will be determined at the end of the procedure
measure: Proportion of participants in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR)
timeFrame: The presence or absence of at least one polyp will be determined at the end of the procedure
measure: 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)
timeFrame: The presence or absence of at least one polyp will be determined at the end of the procedure
measure: 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)
timeFrame: The presence or absence of at least one polyp will be determined at the end of the procedure
measure: Polyp characteristics and location
timeFrame: Assessed over duration of colonoscopy procedure and at time of 14 day post-colonoscopy review (once histology is known)
measure: Sessile Serrated Polyp (SSP) detection rate
timeFrame: SSP Detection Rate will be calculated at the time of study completion, expected to be 18 months
measure: Colorectal Cancer (CRC) detection rate
timeFrame: CRC Detection Rate will be calculated at the time of study completion, expected to be 18 months
measure: Advanced Adenoma (AA) detection rate
timeFrame: AA Detection Rate will be calculated at the time of study completion, expected to be 18 months
measure: Caecal Intubation Rate
timeFrame: Caecal Intubation Rate will be calculated at the time of study completion, expected to be 18 months
measure: Insertion time to caecum
timeFrame: Measured during colonoscopy within the study.
measure: Total Procedure Time
timeFrame: Measured during colonoscopy within the study.
measure: Total Withdrawal Time (in absence of polyps)
timeFrame: Measured during colonoscopy within the study.
measure: Colonoscopist-assessed patient comfort score
timeFrame: Measured during colonoscopy within the study.
measure: Nurse-assessed patient comfort score
timeFrame: Measured during colonoscopy within the study.
measure: Patient-Reported Experience
timeFrame: Assessed one day after the procedure
measure: Patient-Reported Health-Related Quality of Life
timeFrame: Assessed one day after the procedure
measure: Projected future endoscopy workload
timeFrame: Assessed immediately after colonoscopy
measure: MAP according to BCSP status of colonoscopist
timeFrame: At the time of 14-day review
measure: ADR according to BCSP status of colonoscopist
timeFrame: At the time of 14-day review
measure: Change in number of adenomas detected per colonoscopy, for each colonoscopist, over the course of the study, as indicated by MAP
timeFrame: At the time of 14-day review
measure: 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.
timeFrame: At the time of 14-day review
measure: Change in number of adenomas detected per participant, for each participating colonoscopist, from pre-study to intra-study (SC arm only)
timeFrame: At the time of 14-day review
measure: 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)
timeFrame: At the time of 14-day review
Other outcomes:
measure: Cost-effectiveness of GGC versus SC
timeFrame: Costs associated with each participant's procedure and care will be calculated at time of 14-day review
measure: Number of adenomas per participant detected at colonoscopy, amongst colonoscopists not participating in the study, as indicated by MAP
timeFrame: At time of 14-day review
measure: Proportion of participants in whom at least one adenoma is detected at colonoscopy, by colonoscopists not participating in the study, as indicated by ADR
timeFrame: At time of 14-day review
Locations:
city: Hartlepool
country: United Kingdom
facility: North Tees and Hartlepool NHS Foundation Trust
state: County Durham
city: Kendal
country: United Kingdom
facility: University Hospitals of Morecambe Bay NHS Foundation Trust
state: Cumbria
city: North Shields
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
state: North Tyneside
city: Kettering
country: United Kingdom
facility: Kettering General Hospital NHS Foundation Trust
state: Northamptonshire
city: Worthing
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust
state: Sussex
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
state: Teesside
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle-upon-Tyne Hospitals NHS Trust
state: Tyne & Wear
city: Sunderland
country: United Kingdom
facility: South Tyneside and Sunderland NHS Foundation Trust
state: Tyne And Wear
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
state: West Midlands
city: Bolton
country: United Kingdom
facility: Bolton NHS Foundation Trust
Study officials:
affiliation: Newcastle University, South Tyneside and Sunderland NHS Foundation Trust
name: Colin J Rees, MBBS
role: STUDY_DIRECTOR
References:
citation: Seager A, Sharp L, Hampton JS, Neilson LJ, Lee TJW, Brand A, Evans R, Vale L, Whelpton J, Rees CJ. Trial protocol for COLO-DETECT: A randomized controlled trial of lesion detection comparing colonoscopy assisted by the GI Genius artificial intelligence endoscopy module with standard colonoscopy. Colorectal Dis. 2022 Oct;24(10):1227-1237. doi: 10.1111/codi.16219. Epub 2022 Jun 28.