Polyp REcognition Assisted by a Device Interactive Characterization Tool - The PREDICT Study

Study Overview
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Brief Summary
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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 (0.3% of evolution towards advanced adenoma and up to 0.08% 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: 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; 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.

Official Title
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Polyp REcognition Assisted by a Device Interactive Characterization Tool - The PREDICT Study

Conditions
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Artificial Intelligence

Intervention / Treatment
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* Device: GI Genius CADe system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 40-80 undergoing screening colonoscopy for CRC Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation. Exclusion Criteria: subjects positive to Fecal Immunochemical Test or Fecal Occult Blood Test; subjects undergoing CRC surveillance colonoscopy subject at high risk for CRC subjects with a personal history of CRC, IBD or hereditary polyposic or non-polyposic syndromes; patients with previous resection of the sigmoid rectum; patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings; patients who perform an emergency colonoscopy.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Interficial Intelligence<br>Each patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available. | Device: GI Genius CADe system<br>* Each patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Predictive Value of histology prediction on diminutive (≤5 mm) rectosigmoid polyps |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement in assignment of post-polypectomy surveillance intervals | Agreement in assignment of post-polypectomy surveillance intervals according to established guidelines between: the assignment identified according to the combined GI Genius CADx histology prediction for diminutive (≤5 mm) polyps and histology for larger polyps (> 5 mm), and the assignment identified according to histology only. | 1 day |