Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04723758
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2021-01-05
Brief Title:
COLO-DETECT Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy
Sponsor:
South Tyneside and Sunderland NHS Foundation Trust
Organization:
South Tyneside and Sunderland NHS Foundation Trust
Study Overview
Official Title:
COLO-DETECT A Randomised Controlled Trial of Lesion Detection at Colonoscopy Using the GI Genius Artificial Intelligence Platform
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 21-WS-003 | OTHER | None | None |
| 286426 | OTHER | None | None |
| 10451355 | OTHER | ISRCTN | None |