An interventional study of GI Genius CADx device in Colonic Polyp, sponsored by Nuovo Regina Margherita Hospital. Completed at 1 site in Italy. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-08-06.
Sponsored by Nuovo Regina Margherita Hospital · Not applicable, Interventional, and Other
This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the CE-marked GI Genius CADx device. Colonoscopy will be performed according to the standard practice.
318 studies on the registry are indexed under Colonic Polyps; 54 are open to participants now.
This study's enrollment of 165 is below the median of 270 across 215 interventional studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →This is the only study on the registry with Nuovo Regina Margherita Hospital as lead sponsor.
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Exclusion Criteria:
Device: GI Genius CADx device
GI Genius System is an Intelligent Endoscopy Module designed to be an adjunct to video colonoscopy with the purpose of supporting the operating physician with artificial intelligence during colonoscopy. GI Genius CADx is the AI software that provides a histology prediction of framed polyps during real-time colonoscopy, with each polyp being classified as adenoma or non-adenoma.
Negative Predictive Value (NPV)
Negative Predictive Value (NPV) of GI Genius CADx optical diagnosis on diminutive (≤5 mm) rectosigmoid polyps
Time frame: 4 months
Post-polypectomy surveillance interval
Agreement in assignment of post-polypectomy surveillance intervals of the enrolled patients according to established guidelines between the combined use of GI Genius CADx as optical diagnosis for diminutive (≤5 mm) polyps and conventional histology as diagnostic tool for polyps \> 5 mm, and histology as diagnostic tool for all the resected polyps (regardless of size or location)
Time frame: 4 months
Performance metrics of GI Genius CADx
Sensitivity, Specificity, Accuracy, PPV and NPV of GI Genius CADx optical diagnosis
Time frame: 4 months
Performance metrics of the endoscopist with the aid of GI Genius CADx
Sensitivity, Specificity, Accuracy, PPV and NPV of the optical diagnosis of endoscopists assessing lesions in white-light with the help of GI Genius CADx.
Time frame: 4 months
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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