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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interficial Intelligence | Each patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GI Genius CADe system | Device | Each patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Negative Predictive Value of histology prediction on diminutive (≤5 mm) rectosigmoid polyps | 1 day |
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, Specificity, Accuracy, PPV and NPV of GI Genius CADx histology prediction and endoscopist assessment on all the identified lesions | 1 day |
Inclusion Criteria:
Exclusion Criteria:
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Patients aged 40-80 undergoing colonoscopy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy Unit, Humanitas Research Hospital | Rozzano | Milano | 20089 | Italy |
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| 1 day |