Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04589078
Status:
COMPLETED
Last Update Posted:
2021-05-12
First Post:
2020-10-13
Brief Title:
Polyp REcognition Assisted by a Device Interactive Characterization Tool - The PREDICT Study
Sponsor:
Cosmo Artificial Intelligence-AI Ltd
Organization:
Cosmo Pharmaceuticals NV
Study Overview
Official Title:
Polyp REcognition Assisted by a Device Interactive Characterization Tool - The PREDICT Study
Status:
COMPLETED
Status Verified Date:
2021-05
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:
PREDICT
Brief Summary:
Diminutive colorectal polyps 5 mm represent most of the polyps detected during colonoscopy especially in the rectum-sigmoid tract The characterization of these polyps by virtual chromoendoscopy is recognized as a key element for innovative imaging techniques As a matter of facts diminutive colorectal polyps are very frequent and if located in the rectosigmoid colon they present a very low malignant risk 03 of evolution towards advanced adenoma and up to 008 of evolution towards invasive carcinoma The real-time characterization would allow to identify the lowest risk polyps hyperplastic subtype to leave them in situ or if resected not to send them for histological examination allowing a huge saving in healthcare associated costs
Recently the American Society for Gastrointestinal Endoscopy ASGE Technology Committee established the Preservation and Incorporation of Valuable endoscopic Innovations PIVI document specific for real-time histological assessment for tiny colorectal polyps to establish reference quality thresholds Two performance standards have been developed to guide the use of advanced imaging
1 for diminutive polyps to be resected and discarded without pathologic assessment endoscopic technology when used with high confidence used to determine histology of polyps 5mm in size when combined with the histopathology assessment of polyps 5 mm in size should provide a 90 agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps
2 in order for a technology to be used to guide the decision to leave suspected rectosigmoid hyperplastic polyps 5 mm in size in place without resection the technology should provide 90 negative predictive value when used with high confidence for adenomatous histology
Computer-Aided-Diagnosis CAD is an artificial intelligence-based tool that would allow rapid and objective characterization of these lesions The GI Genius CADx was developed to help endoscopists in their clinical practices for polyps characterization
Recently the American Society for Gastrointestinal Endoscopy ASGE Technology Committee established the Preservation and Incorporation of Valuable endoscopic Innovations PIVI document specific for real-time histological assessment for tiny colorectal polyps to establish reference quality thresholds Two performance standards have been developed to guide the use of advanced imaging
1 for diminutive polyps to be resected and discarded without pathologic assessment endoscopic technology when used with high confidence used to determine histology of polyps 5mm in size when combined with the histopathology assessment of polyps 5 mm in size should provide a 90 agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps
2 in order for a technology to be used to guide the decision to leave suspected rectosigmoid hyperplastic polyps 5 mm in size in place without resection the technology should provide 90 negative predictive value when used with high confidence for adenomatous histology
Computer-Aided-Diagnosis CAD is an artificial intelligence-based tool that would allow rapid and objective characterization of these lesions The GI Genius CADx was developed to help endoscopists in their clinical practices for polyps characterization
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None