Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05514301
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2022-08-22
Brief Title:
Clinical Validation of Polydeep an Artificial Intelligence-based Computer-aided Polyp Detection CADe and Characterization CADx System
Sponsor:
Fundacin Biomedica Galicia Sur
Organization:
Fundacin Biomedica Galicia Sur
Study Overview
Official Title:
Polydeep Advance I Prospective Diagnostic Tests Trial With a Paired Study Design
Status:
COMPLETED
Status Verified Date:
2022-05
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 1 is an unicentric prospective diagnostic tests trial with a paired study design The hypothesis of the study is that Polydeep a CAD system is more sensitive than a blinded endoscopists for the detection of colorectal polyps in a high definition colonoscopy
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 international 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 The aim of Polydeep advance 1 is to perform the clinical validation within a diagnostic test trial with a paired study design We will compare the sensitivity of Polydeep to endoscopists blinded to Polydeep in high definition colonoscopy
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 international 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 The aim of Polydeep advance 1 is to perform the clinical validation within a diagnostic test trial with a paired study design We will compare the sensitivity of Polydeep to endoscopists blinded to Polydeep in high definition colonoscopy
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