Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05512793
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2022-08-22
Brief Title:
Clinical Validation of PolyDeep an Artificial Intelligence-based Computer-aided Polyp Detection CADe and Characterization CADx System Polydeep Advance 2
Sponsor:
Fundacin Biomedica Galicia Sur
Organization:
Fundacin Biomedica Galicia Sur
Study Overview
Official Title:
PolyDeep Advance 2 Clinical Validation of PolyDeep Randomized Clinical Trial With a Tandem Colonoscopy Design
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:
This study is a clinical validation of PolyDeep a computer-aided polyp detection CADe and characterization CADx system PolyDeep Advance 2 is a multicentric randomized clinical trial with a tandem colonoscopy design The hypothesis of this study is that Polydeep assisted colonoscopy will reduce the number of missed adenomas in the first withdrawal
Detailed Description:
Colorectal cancer CRC is the most frequently cancer in western world A fundamental tool for detection and prevention is the colonoscopy The detection and endoscopic resection of colorectal polyps the precursor lesion of CRC can reduce CRC incidence and mortality Adenoma detection rate is the most used endoscopic quality indicator The improvement of this indicator is related to the reduction of postcolonoscopy CRC incidence and mortality
Colorectal polyp diagnosis is based on endoscopic resection and histological analysis An accurate optical diagnosis could avoid histological lesion of smaller lesions reducing the costs associated with histological diagnosis The NICE NBI International Colorectal Endoscopic Classification has proposed the use of high definition endoscopes that have Narrow Band Imaging However NICE must be used by endoscopists who are sufficiently prepared and who have overcome the learning curve Therefore optical histology diagnosis with high accuracy independently of the center and the endoscopist is necessary
Computer Aid Diagnosis CAD systems based on Artificial Intelligence are experiencing exponential development in the field of medical image analysis The development of the CAD system is based on the creation of large databases of endoscopic images andor videos on the training development and validation of diagnostic algorithms in such databases and finally on prospective clinical validation in patients undergoing colonoscopy The goal of CAD systems in colonoscopy is double First it aims to increase the detection of polyps CADe in general and of adenomas and serrated lesions in particular The second objective is to characterize CADx the histology of detected lesion
PolyDeep CAD is a functional prototype It is capable of detecting locating and classifying colorectal polyps In vivo validation data shows that PolyDeep has high diagnostic accuracy for polyp identification and that this accuracy can be accommodated This clinical trial is part of the clinical validation of PolyDeep We will perform a randomized clinical trial with a tandem colonoscopy design with adenoma miss rate as the main objective
Colorectal polyp diagnosis is based on endoscopic resection and histological analysis An accurate optical diagnosis could avoid histological lesion of smaller lesions reducing the costs associated with histological diagnosis The NICE NBI International Colorectal Endoscopic Classification has proposed the use of high definition endoscopes that have Narrow Band Imaging However NICE must be used by endoscopists who are sufficiently prepared and who have overcome the learning curve Therefore optical histology diagnosis with high accuracy independently of the center and the endoscopist is necessary
Computer Aid Diagnosis CAD systems based on Artificial Intelligence are experiencing exponential development in the field of medical image analysis The development of the CAD system is based on the creation of large databases of endoscopic images andor videos on the training development and validation of diagnostic algorithms in such databases and finally on prospective clinical validation in patients undergoing colonoscopy The goal of CAD systems in colonoscopy is double First it aims to increase the detection of polyps CADe in general and of adenomas and serrated lesions in particular The second objective is to characterize CADx the histology of detected lesion
PolyDeep CAD is a functional prototype It is capable of detecting locating and classifying colorectal polyps In vivo validation data shows that PolyDeep has high diagnostic accuracy for polyp identification and that this accuracy can be accommodated This clinical trial is part of the clinical validation of PolyDeep We will perform a randomized clinical trial with a tandem colonoscopy design with adenoma miss rate as the main objective
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