NCT04723758

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

COLO-DETECT: A Randomised Controlled Trial of Lesion Detection at Colonoscopy Using the GI Genius Artificial Intelligence Platform

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,032 (actual)
• Sponsor: South Tyneside and Sunderland NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colonic Polyp
• Colorectal Polyp
• Colorectal Adenoma
• Colorectal Adenomatous Polyp
• Colorectal SSA
• Sessile Serrated Adenoma
• Sessile Colonic Polyp

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-03-29
• Primary completion: 2023-04-06
• Completion: 2023-04-20
• First posted: 2021-01-26
• Last updated: 2023-11-28

Locations

10 sites across 1 country: United Kingdom