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

South Tyneside and Sunderland NHS Foundation Trust

Status: Completed

Conditions: Colonic Polyp; Colorectal Adenomatous Polyp; Colorectal Adenoma; Colorectal SSA; Sessile Colonic Polyp; Colorectal Polyp; Sessile Serrated Adenoma

Treatments: Device: GI Genius-assisted diagnostic colonoscopy; Diagnostic Test: Diagnostic Colonoscopy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04723758

21-WS-003 (Other Identifier)

10451355 (Other Identifier)

COLO-DETECT

286426 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,032 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,032 participants in 2 patient groups

GI Genius-assisted colonoscopy (GGC)

Experimental group

Description:

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.

Treatment:

Device: GI Genius-assisted diagnostic colonoscopy

Standard Colonoscopy (SC)

Active Comparator group

Description:

In the SC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure.

Treatment:

Diagnostic Test: Diagnostic Colonoscopy