Ignite Creation Date:
2024-05-06 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05236790
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2022-02-02
Brief Title:
Evaluation of CAD-EYESCALE-EYE for Detection Classification and Measurement of Colorectal Polyps a Prospective Study
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Performance Evaluation of CAD-EYE and SCALE-EYE for Detection Classification and Measurement of Colorectal Polyps a Prospective Study
Status:
COMPLETED
Status Verified Date:
2023-09
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:
The investigators hypothesize that the clinical implementation of an AI system is an optimal tool to monitor audit and improve the detection and classification of polyps during colonoscopy The purpose of this prospective clinical cohort study is to evaluate the performance of the SCALE-EYE virtual scale for measuring polyp size when used during live colonoscopies The investigators also wish to evaluate CAD-eye for detection and classification of polyp histology It is hypothesized that CAD-eye and SCALE-EYE can function in real-time practice with high accuracy
Detailed Description:
Detailed Description
This study will be conducted in several phases phase 1 will evaluate the feasibility of using CAD-eye in real-time practice training endoscopists to work with this platform obtaining preliminary data on relative size measurement accuracy when using scale eye testing feasibility of fresh polyp specimen size measurement and determining the sample size and reference standard for evaluating SCALE-EYE during the subsequent phases of the study in randomized controlled trials Phase 2 will evaluate relative size measurement accuracy of SCALE-EYE compared to visual size estimation and CADeCADx performance in a randomized controlled trial Scale-eye will further be validated through video-based analysis comparing different size measurement methods scale eye snare forceps visual assessment with different groups of endoscopists experts staff gastroenterologists trainees evaluating videos showing video sequences that show the polyps either with scale eye visual or instrument information Furthermore fresh specimen size measurement and pathology-based size including different ways to prepare specimens for pathology sectioning will be evaluated for agreement between size measurement methods and tissue shrinkage effects Phase 3 will evaluate relative size measurement accuracy of SCALE-EYE compared to snare-based size estimation
Eligible patients will be adults aged 45 to 80 years referred to CHUM for diagnostic screening or surveillance colonoscopy Patients will undergo colonoscopies using CAD-eye and the size of all polyps detected will be estimated by different subjective and objective methods All polyp size measurements will be videorecorded Video recordings with different measurement instruments forceps snare scale eye visual assessment will be assessed with different groups of endoscopists experts staff gastroenterologists trainees for size measurements through online video presentations in a randomized order The main results of this study are to evaluate the relative accuracy of SCALE-EYE for polyp size estimation and the adenoma detection rates sensitivity specificity NPV for CAD-eye for polyp detection and classification We will also calculate other characteristics of CAD-eye and SCALE-EYE tests the rate of divergence andor agreement between subjective and objective methods of polyp size estimation the agreement between surveillance intervals based on optical diagnosis by CAD-eye and pathological findings and the false positive rate and latency for polyp detection
This study will be conducted in several phases phase 1 will evaluate the feasibility of using CAD-eye in real-time practice training endoscopists to work with this platform obtaining preliminary data on relative size measurement accuracy when using scale eye testing feasibility of fresh polyp specimen size measurement and determining the sample size and reference standard for evaluating SCALE-EYE during the subsequent phases of the study in randomized controlled trials Phase 2 will evaluate relative size measurement accuracy of SCALE-EYE compared to visual size estimation and CADeCADx performance in a randomized controlled trial Scale-eye will further be validated through video-based analysis comparing different size measurement methods scale eye snare forceps visual assessment with different groups of endoscopists experts staff gastroenterologists trainees evaluating videos showing video sequences that show the polyps either with scale eye visual or instrument information Furthermore fresh specimen size measurement and pathology-based size including different ways to prepare specimens for pathology sectioning will be evaluated for agreement between size measurement methods and tissue shrinkage effects Phase 3 will evaluate relative size measurement accuracy of SCALE-EYE compared to snare-based size estimation
Eligible patients will be adults aged 45 to 80 years referred to CHUM for diagnostic screening or surveillance colonoscopy Patients will undergo colonoscopies using CAD-eye and the size of all polyps detected will be estimated by different subjective and objective methods All polyp size measurements will be videorecorded Video recordings with different measurement instruments forceps snare scale eye visual assessment will be assessed with different groups of endoscopists experts staff gastroenterologists trainees for size measurements through online video presentations in a randomized order The main results of this study are to evaluate the relative accuracy of SCALE-EYE for polyp size estimation and the adenoma detection rates sensitivity specificity NPV for CAD-eye for polyp detection and classification We will also calculate other characteristics of CAD-eye and SCALE-EYE tests the rate of divergence andor agreement between subjective and objective methods of polyp size estimation the agreement between surveillance intervals based on optical diagnosis by CAD-eye and pathological findings and the false positive rate and latency for polyp detection
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