Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160466
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-11-29
Brief Title:
Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in Follow-up Patients in a Screening Setting
Sponsor:
Fondazione Poliambulanza Istituto Ospedaliero
Organization:
Fondazione Poliambulanza Istituto Ospedaliero
Study Overview
Official Title:
Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in Follow-up Patients in a Screening Setting
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:
GENIAL-CO FU
Brief Summary:
The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy The main question it aims to answer is the Adenoma Detection Rate ADR Participants undergoing colonoscopy for follow-up in a screening setting will be randomized in a 11 ratio to either receive Computer-Aided Detection CADe colonoscopy or a conventional colonoscopy CC GI Genius is the AI software that will be used in the present trial and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions such as polyps and adenomas including those with flat non-polypoid morphology during standard screening and surveillance endoscopic mucosal evaluations It is not intended to replace histopathological sampling as a means of diagnosisResearchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly
Detailed Description:
en if colonoscopy is considered the reference standard for the detection of colonic neoplasia polyps are still missed In large administrative cohort or case-control studies the risk of early post-colonoscopy cancer appeared to be independently predicted by a relatively low polypadenoma detection rate The adenoma detection rate among different endoscopists has been shown to be strictly related with the risk of post-colonoscopy interval cancer When considering the very high prevalence of advanced neoplasia in the FIT-positive enriched population the risk of post-colonoscopy interval cancer due to a suboptimal quality of colonoscopy may be substantial Available evidence justifies therefore the implementation of efforts aimed at improving adenoma detection rate based on retraining interventions and on the adoption of innovative technologies designed to enhance the accuracy of the endoscopic examinationNowadays Artificial intelligence AI is gaining increased attention and investigation since it seems to improve the quality of medical diagnosis and treatment In the field of gastrointestinal endoscopy two potential roles of AI in colonoscopy have been examined so far automated polyp detection CADe and automated polyp histology characterization CADx CADe can minimize the probability of missing a polyp during colonoscopy thereby improving the adenoma detection rate ADR and potentially decreasing the incidence of interval cancer GI Genius is the AI software that will be used in the present trial The software is developed by Medtronic Inc Dublin Ireland and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions such as polyps and adenomas including those with flat non-polypoid morphology during standard screening and surveillance endoscopic mucosal evaluations It is not intended to replace histopathological sampling as a means of diagnosis
The objective of this study was to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy SC As the risk of progression is higher for large than for small adenomas the specific contribution of the new technique in reducing the miss rate of large neoplasms represents an important outcome to be assessed in the study In addition given the suggested association of a higher miss-rate of serrated and flat lesions with an increased risk of early post-colonoscopy CRC the benefit of the new technique in reducing the miss rate of these lesions will be assessed
The objective of this study was to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy SC As the risk of progression is higher for large than for small adenomas the specific contribution of the new technique in reducing the miss rate of large neoplasms represents an important outcome to be assessed in the study In addition given the suggested association of a higher miss-rate of serrated and flat lesions with an increased risk of early post-colonoscopy CRC the benefit of the new technique in reducing the miss rate of these lesions will be assessed
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