Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04442607
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2020-06-18
Brief Title:
Clinical vAliDation of ARTificial Intelligence in POlyp Detection
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Clinical vAliDation of ARTificial Intelligence in POlyp Detection
Status:
COMPLETED
Status Verified Date:
2022-11
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:
CAD-ARTIPOD
Brief Summary:
This study is an open label unblinded non-randomized interventional study comparing the investigational artificial intelligence tool with the current gold standard Data acquisition will be obtained during one scheduled colonoscopic procedure by a trained endoscopist During insertion no action will be taken colonoscopy is performed following the standard of care Once withdrawal is started a second observer not a trained endoscopist but person trained in polyp recognition will start the bedside Artificial intelligence AI tool connected to the endoscopes tower for detection This second observer is trained in assessing endoscopic images to define the AI tools outcome Due to the second observer watching the separate AI screen the endoscopist is blinded of the AI outcome When a detection is made by the AI system that is not recognized by the endoscopist the endoscopist will be asked to relocate that same detection and to reassess the lesion and the possible need of therapeutic action All detections are separately counted and categorized by the second observer All polyp detections will be removed following standard of care for histological assessment The entire colonoscopic procedure is recorded via a separate linked video-recorder
Detailed Description:
This is an investigator-initiated non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided detection CADe tool for colorectal polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy Consecutive patients referred for a screening surveillance or diagnostic colonoscopy will be included
Patients will undergo a standard colonoscopy performed by a trained endoscopist A second observer who is not a trained endoscopist will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows 1 true positive 2 false negative or 3 false positive In case of a detection of the AI-system that was not seen by the endoscopist or unclear to the second observer the second observer will ask to re-evaluate the indicated region to determine whether after second look the endoscopist has to take extra action The entire procedure will be recorded
There are no additional risks specific to the use of the AI tool to be taken into account General risk of colonoscopy ie perforation bleeding or post-polypectomy syndrome could occur with the same frequency as that of a colonoscopy without the use of this AI tool
All patients will receive a standard of care protocol during their colonoscopy The AI system can only have a beneficial outcome for the patient a better polyp detection as it has shown to be non-inferior in terms of accuracy when compared to high detecting endoscopist in our pilot trial
Patients will undergo a standard colonoscopy performed by a trained endoscopist A second observer who is not a trained endoscopist will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows 1 true positive 2 false negative or 3 false positive In case of a detection of the AI-system that was not seen by the endoscopist or unclear to the second observer the second observer will ask to re-evaluate the indicated region to determine whether after second look the endoscopist has to take extra action The entire procedure will be recorded
There are no additional risks specific to the use of the AI tool to be taken into account General risk of colonoscopy ie perforation bleeding or post-polypectomy syndrome could occur with the same frequency as that of a colonoscopy without the use of this AI tool
All patients will receive a standard of care protocol during their colonoscopy The AI system can only have a beneficial outcome for the patient a better polyp detection as it has shown to be non-inferior in terms of accuracy when compared to high detecting endoscopist in our pilot trial
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