NCT05236790

Evaluation of CAD-EYE/SCALE-EYE for Detection, Classification, and Measurement of Colorectal Polyps: a Prospective Study

Performance Evaluation of CAD-EYE and SCALE-EYE for Detection, Classification, and Measurement of Colorectal Polyps: a Prospective Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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 CADe/CADx 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 and/or 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.

Conditions

• Colorectal Polyp
• Colorectal Adenoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale Eye	Detection and classification and size measurement of polyp by Artificial Intelligence (CADeye) and Scale Eye This study will be conducted in multiple phases: phase 1 (pilot phase, n=40 polyps, about 60 patients) to evaluate the feasibility of applying Scale Eye in real-time practice, training endoscopists to work with CADe and CADx and determining the sample size and reference standard to evaluate SCALE-EYE during the second phase of the study (randomized controlled trial), phase 2 will evaluate the performance of SCALE-EYE and CAD-eye in real-time practice. The sample size for phase 2 (RCT comparing visual with scasle eye) will be based on the pilot data allowing to compare relative accuracy of size measurement with scale eye versus visual size estimation. After completion of phase 2 later phases will use instruments such as snare and/or forceps as reference measurement devices compared to relative accuracy of measurement when using scale eye.

Timeline

• Start date: 2022-06-20
• Primary completion: 2023-06-20
• Completion: 2023-06-20
• First posted: 2022-02-11
• Last updated: 2023-10-02

Locations

1 site across 1 country: Canada