Ignite Creation Date:
2024-05-06 @ 6:14 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05594576
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2022-10-21
Brief Title:
Comparison of the ENDOCUFF VISION Endoscopy Cap Coupled With GI GENIUS Artificial Intelligence Compared to Each Device Alone in Improving Colonic Adenoma Detection Rate During Colonoscopy
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
Official Title:
Comparison of the ENDOCUFF VISION Endoscopy Cap Coupled With GI GENIUS Artificial Intelligence Compared to Each Device Alone in Improving Colonic Adenoma Detection Rate During Colonoscopy
Status:
RECRUITING
Status Verified Date:
2024-02
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:
COLODETECT2
Brief Summary:
Colorectal cancer is the 2nd most common cause of death by cancer Screening is therefore essential with a positive impact for prevention and in the visualization and removal of colonic adenomas pre-cancerous lesions of colorectal cancer
The colonic adenoma detection rate CADR the gold standard for colonoscopy screening and screening studies is the ratio of the number of colonoscopies with at least one histologically verified colonic adenoma to the total number of colonoscopies performed in a center It varies between 25 and 45 depending on the center There is a large inter-operator CADR variability which has been linked to an increased incidence and excess mortality in colorectal cancers
To improve this detection rate several innovative techniques have been developed
The endoscopic cap helps improve this detection rate it is a 2cm tip with double row of plastic wings fixed to the distal end of the colonoscope which acts by unfolding the colonic haustrations allowing a better visualization of adenomas and more particularly those of sessile morphology and sigmoidal location Several multicenter studies have shown an improvement in the adenoma detection rate with this device compared to screening colonoscopy alone with an adenoma detection rate optimization of 14 Since then other devices such as the Endocuff have emerged with comparable efficacy The Medtronic GI GENIUS system integrates artificial intelligence AI to assist in the detection of polyps It automatically identifies these precancerous lesions in real time
The study investigators previously performed a retrospective pilot study COLODETECT comparing colonoscopy alone as a control group against AI alone and against the combined cap AI This study showed encouraging results in terms of colonic adenoma detection rate 60 for the AI cap group versus 37 for the AI alone group versus 33 for the colonoscopy alone group p0037 However it requires a higher level of evidence to be validated in practice This prospective COLODETECT2 study estimated an a priori expected difference between AI - Cap and AI alone of about 15 CADR
The GI GENIUS artificial intelligence system and the ENDOCUFF VISION endoscopic cap have separately proven their effectiveness in terms of colonic adenoma detection compared to colonoscopy alone However some limitations remain existence of false positives mucosal folds residues some morphological types still difficult to recognize scalloped adenomas non visualized colonic lesions
This study therefore focuses on the possible complementarity of these 2 medical devices in order to maximize the detection rate of colonic adenomas and thus overcome the limitations of these two techniques by optimizing the visualization of these precancerous lesions and consequently increasing the impact of colorectal cancer screening
The study authors hypothesize that the combination of GI GENIUS AI coupled with the ENDOCUFF VISION endoscopy cap provides a better colonic adenoma detection rate CAD during colonoscopy than either GI GENIUS AI alone or the ENDOCUFF VISION cap alone
The colonic adenoma detection rate CADR the gold standard for colonoscopy screening and screening studies is the ratio of the number of colonoscopies with at least one histologically verified colonic adenoma to the total number of colonoscopies performed in a center It varies between 25 and 45 depending on the center There is a large inter-operator CADR variability which has been linked to an increased incidence and excess mortality in colorectal cancers
To improve this detection rate several innovative techniques have been developed
The endoscopic cap helps improve this detection rate it is a 2cm tip with double row of plastic wings fixed to the distal end of the colonoscope which acts by unfolding the colonic haustrations allowing a better visualization of adenomas and more particularly those of sessile morphology and sigmoidal location Several multicenter studies have shown an improvement in the adenoma detection rate with this device compared to screening colonoscopy alone with an adenoma detection rate optimization of 14 Since then other devices such as the Endocuff have emerged with comparable efficacy The Medtronic GI GENIUS system integrates artificial intelligence AI to assist in the detection of polyps It automatically identifies these precancerous lesions in real time
The study investigators previously performed a retrospective pilot study COLODETECT comparing colonoscopy alone as a control group against AI alone and against the combined cap AI This study showed encouraging results in terms of colonic adenoma detection rate 60 for the AI cap group versus 37 for the AI alone group versus 33 for the colonoscopy alone group p0037 However it requires a higher level of evidence to be validated in practice This prospective COLODETECT2 study estimated an a priori expected difference between AI - Cap and AI alone of about 15 CADR
The GI GENIUS artificial intelligence system and the ENDOCUFF VISION endoscopic cap have separately proven their effectiveness in terms of colonic adenoma detection compared to colonoscopy alone However some limitations remain existence of false positives mucosal folds residues some morphological types still difficult to recognize scalloped adenomas non visualized colonic lesions
This study therefore focuses on the possible complementarity of these 2 medical devices in order to maximize the detection rate of colonic adenomas and thus overcome the limitations of these two techniques by optimizing the visualization of these precancerous lesions and consequently increasing the impact of colorectal cancer screening
The study authors hypothesize that the combination of GI GENIUS AI coupled with the ENDOCUFF VISION endoscopy cap provides a better colonic adenoma detection rate CAD during colonoscopy than either GI GENIUS AI alone or the ENDOCUFF VISION cap alone
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