An observational study in Colonic Polyp and Adenoma Colon, sponsored by Valduce Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by Valduce Hospital · Observational
The endoscopist performances in the optical diagnosis (OD) of colonic polyps with the available technologies vary widely across centers and across endoscopists. The OD process is strictly related to the operator training and expertise. Most of the available studies in optical characterization have been carried out by expert endoscopist in tertiary high volume centers, and weren't replied on large unselected populations. For these reasons, at the moment the optical characterization of polypoid lesions can't replace, in the everyday clinical practice, the histopathological evaluation of resected polyps. Artificial intelligence (AI)-based systems have the potential to make optical characterization process of colonic polyps easier and more reliable, thus supporting the endoscopist in the application of leave-in-situ and of resect-and-discard strategies. The implementation of such strategies would lead to a significant economic saving and a decrease of risks and complications related to unnecessary polypectomy. GI-Genius System (Medtronic Inc, Minneaopolis, USA) is a CNN-based algorithm allowing an automatic OD of colonic polyps. This system does not require dedicated light setting for polyp evaluation as it works with white light high definition images, which are the actual standard in every endoscopic unit. During colonoscopy, when a polyp is framed within the screen, a green detection box surrounds the polyp and the system automatically provides (whenever possible) the optical diagnosis labeling the polyp as "adenoma or non-adenoma". When the automatic polyp charaterization is unfeasible the label "no prediction" appears. Nowadays only few data about the feasibility and performances of this system in clinical practice are available. In addition published studies are mostly focused on technical rather thann clinical issues. The present prospective observational trial is primarily aimed at evaluating the diagnostic accuracy of optical characterization of colonic polyps \<= 1 cm using GI-Genius System in daily clinical practice, having histopathology examination as reference standard.
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's enrollment of 500 is above the median of 411 across 115 observational studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Valduce Hospital is the lead sponsor of 29 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive adults (18-85 years) outpatients referred for colonoscopy are invited to participate in the present study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Consecutive outpatients undergoing colonoscopy for one of the following indication:
Exclusion Criteria:
Diagnostic accuracy of CADx in evaluating small colonic polyps
Numer of correctly characterized polyps using AI/total number of detected polyps
Time frame: Entire study duration (3 months)
Feasibility of CADx in evaluating small colonic polyps
Number of characterizable polyps using AI/total number of detected polyps
Time frame: Entire study duration (3 months)
Sensitivity
CADx sensitivity (rate of TP/TP+FN) will be calculated having histopathology as reference standard and according to polyp size and location
Time frame: Entire study duration (3 months)
specificity
CADx specificity (rate of TN/TN+FP) will be calculated having histopathology as reference standard according to polyp size and location
Time frame: Entire study duration (3 months)
Positive predictive value
CADx positive predictive value (rate of TP/TP+FP) will be calculated having histopathology as reference standard according to polyp size and location
Time frame: Entire study duration (3 months)
Negative predictive value
CADX negative predictive value (rate of TN/TN+FN) will be calculated having histopathology as reference standard according to polyp size and location
Time frame: Entire study duration (3 months)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Valduce Hospital