Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04676308
Status:
COMPLETED
Last Update Posted:
2022-09-14
First Post:
2020-12-15
Brief Title:
The CERTAIN Study Combining Endo-cuff in a Randomized Trial for Artificial Intelligence Navigation
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
The CERTAIN Study Combining Endo-cuff in a Randomized Trial for Artificial Intelligence Navigation
Status:
COMPLETED
Status Verified Date:
2022-09
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:
CERTAIN
Brief Summary:
Colonoscopy is clinically used as the gold standard for detection of colon cancer CRC and removal of adenomatous polyps Despite the success of colonoscopy in reducing cancer-related deaths there exists a disappointing level of adenomas missed at colonoscopy Back-to-back colonoscopies have indicated significant miss rates of 27 for small adenomas 5 mm and 6 for adenomas of more than 10 mm in diameter Studies performing both CT colonography and colonoscopy estimate that the colonoscopy miss rate for polyps over 10 mm in size may be as high as 12 The clinical importance of missed lesions should be emphasized because these lesions may ultimately progress to CRC Limitations in human visual perception and other human biases such as fatigue distraction level of alertness during examination increases recognition errors and way of mitigating them may be the key to improve polyp detection and further reduction in mortality from CRC
Recent advances in artificial intelligence AI deep learning DL and computer vision have permitted to develop several AI platforms which have already proved their efficacy in increasing adenoma detection during colonoscopy910 As a matter of fact the improvement in detection due to AI systems is only related to the increased capacity of detecting lesions within the visual field that is dependent on the amount of mucosa exposed by the endoscopist during the scope withdrawal
Increasing the mucosa exposure would theoretically be a complementary strategy to further improve polyps detection A number of distal attachments have been tested to increase the mucosal exposure by flattening mucosal folds including a transparent cap cuff or rings The additional diagnostic yield obtained by the second generation of cuff Endocuff Vision Olympus America Center Valley Pa USA was recently investigated by a meta-analysis of randomized controlled trials showing a significant improvement in adenoma detection rate and adenomas per colonoscopy with a reduction in the mean withdrawal time without any increase in adverse events compared with standard high-definition colonoscopy without any distal attachment
In conclusion technologies providing either mucosal image enhancement Artificial Intelligence assisted colonoscopy or mucosal exposure device Endocuff Vision assisted colonoscopy significantly improved adenoma detection rate ADR However the diagnostic yield obtained by combining the different strategies is still unknown
Recent advances in artificial intelligence AI deep learning DL and computer vision have permitted to develop several AI platforms which have already proved their efficacy in increasing adenoma detection during colonoscopy910 As a matter of fact the improvement in detection due to AI systems is only related to the increased capacity of detecting lesions within the visual field that is dependent on the amount of mucosa exposed by the endoscopist during the scope withdrawal
Increasing the mucosa exposure would theoretically be a complementary strategy to further improve polyps detection A number of distal attachments have been tested to increase the mucosal exposure by flattening mucosal folds including a transparent cap cuff or rings The additional diagnostic yield obtained by the second generation of cuff Endocuff Vision Olympus America Center Valley Pa USA was recently investigated by a meta-analysis of randomized controlled trials showing a significant improvement in adenoma detection rate and adenomas per colonoscopy with a reduction in the mean withdrawal time without any increase in adverse events compared with standard high-definition colonoscopy without any distal attachment
In conclusion technologies providing either mucosal image enhancement Artificial Intelligence assisted colonoscopy or mucosal exposure device Endocuff Vision assisted colonoscopy significantly improved adenoma detection rate ADR However the diagnostic yield obtained by combining the different strategies is still unknown
Detailed Description:
None
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