Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568523
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Study to Evaluate the Diagnostic Performance of Computer-aided Polyp Size Classification of the MAGENTIQ-COLO During Real-time Colonoscopy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an international multicenter study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO
Detailed Description:
Colonoscopy is the gold standard for the detection and removal of premalignant colorectal polyps Recommended post-polypectomy surveillance intervals are primarily based on pathological diagnosis and polyp size However accurate estimation of polyp size remains challenging potentially influencing post-polypectomy surveillance intervals Inaccuracies in size estimation may lead to either unnecessary or prematurely scheduled surveillance colonoscopies when overestimating size or lead to an increased risk of post-colonoscopy colorectal cancer or advanced neoplasia when underestimating size Furthermore diminutive 1-5mm polyps pose challenges due to their high incidence and frequent pathological assessment Proposed strategies to reduce this burden such as the European Society of Gastrointestinal Endoscopy ESGE resect-and-discard strategy are infrequently used as non-expert endoscopists often do not meet diagnostic thresholds when using standard visual inspection The MAGENTIQ-COLO computer-aided diagnosis CADx system by Magentiq Eye LTD Haifa Israel addresses these challenges by providing real-time polyp size estimation and polyp characterization Additionally this study evaluates the diagnostic accuracy of the MAGENTIQ-COLO CADx system in an average-risk screening and surveillance colonoscopy population
The primary objective of the study is to assess the diagnostic performance of the endoscopist performing a MAGENTIQ-COLO CADx-assisted colonoscopy to classify polyps as diminutive 5mm or non-diminutive 5mm compared to the size classification using open biopsy forceps or polypectomy snares of known diameter
This will be measured by comparing the sensitivity and specificity between the two size classifications Secondary objective include
To assess the diagnostic performance of the endoscopist performing a MAGENTIQ-COLO CADx-assisted colonoscopy to diagnose diminutive rectosigmoid colorectal polyps as neoplastic adenoma or sessile serrated lesion SSL with high-confidence compared to the pathology diagnosis This will be measured by the sensitivity and specificity between the two diagnoses
To assess the diagnostic performance of the CADx system in measuring the size in millimeters and the size classification of colorectal polyps compared to the size measurement using open biopsy forceps or polypectomy snare of known diameter this correlation will also be conducted for classifying polyps into diminutive 5mm small 6-9mm and advanced 10mm size categories
The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive 5mm or non-diminutive 5mm compared to the reference gold standard which is the size classification of the colorectal polyp using open biopsy forceps or polypectomy snare of known diameter
This is an international multicenter study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO Study subjects who are already referred for screening or surveillance colonoscopy will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology Endoscopists will assess all colorectal polyps detected during colonoscopy with and without the MAGENTIQ-COLO Diagnostic performance of polyp size classification and optical diagnosis with and without MAGENTIQ-COLO is evaluated with reference to open biopsy forceps or polypectomy snare of known diameter size classification and pathology-based diagnosis respectively There is no formal study subject follow-up Study procedures will be performed intraprocedural during the colonoscopy Final pathological diagnosis will be recorded from the electronic health record
The unit of analysis is the colorectal polyp rather than a study subject The study is planned to include 396 colorectal polyps Based on an expected detection rate of approximately 120 polyps per colonoscopy in the study population we assume that enrollment of 330 subjects will be sufficient to meet the study objectives
The primary objective of the study is to assess the diagnostic performance of the endoscopist performing a MAGENTIQ-COLO CADx-assisted colonoscopy to classify polyps as diminutive 5mm or non-diminutive 5mm compared to the size classification using open biopsy forceps or polypectomy snares of known diameter
This will be measured by comparing the sensitivity and specificity between the two size classifications Secondary objective include
To assess the diagnostic performance of the endoscopist performing a MAGENTIQ-COLO CADx-assisted colonoscopy to diagnose diminutive rectosigmoid colorectal polyps as neoplastic adenoma or sessile serrated lesion SSL with high-confidence compared to the pathology diagnosis This will be measured by the sensitivity and specificity between the two diagnoses
To assess the diagnostic performance of the CADx system in measuring the size in millimeters and the size classification of colorectal polyps compared to the size measurement using open biopsy forceps or polypectomy snare of known diameter this correlation will also be conducted for classifying polyps into diminutive 5mm small 6-9mm and advanced 10mm size categories
The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive 5mm or non-diminutive 5mm compared to the reference gold standard which is the size classification of the colorectal polyp using open biopsy forceps or polypectomy snare of known diameter
This is an international multicenter study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO Study subjects who are already referred for screening or surveillance colonoscopy will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology Endoscopists will assess all colorectal polyps detected during colonoscopy with and without the MAGENTIQ-COLO Diagnostic performance of polyp size classification and optical diagnosis with and without MAGENTIQ-COLO is evaluated with reference to open biopsy forceps or polypectomy snare of known diameter size classification and pathology-based diagnosis respectively There is no formal study subject follow-up Study procedures will be performed intraprocedural during the colonoscopy Final pathological diagnosis will be recorded from the electronic health record
The unit of analysis is the colorectal polyp rather than a study subject The study is planned to include 396 colorectal polyps Based on an expected detection rate of approximately 120 polyps per colonoscopy in the study population we assume that enrollment of 330 subjects will be sufficient to meet the study objectives
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None