An interventional study of Sensitivity of Polydeep vs high experienced endoscopists for colorectal polyp detection in Colorectal Cancer, sponsored by Fundacin Biomedica Galicia Sur. Completed at 1 site in Spain. Open to participants aged 40 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Fundacin Biomedica Galicia Sur · Not applicable, Interventional, and Diagnostic
This study is a clinical validation of Polydeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. Polydeep Advance 1 is an unicentric prospective diagnostic tests trial with a paired study design. The hypothesis of the study is that Polydeep, a CAD system, is more sensitive than a blinded endoscopists for the detection of colorectal polyps in a high definition colonoscopy.
Colorectal cancer (CRC) is the most frequently cancer in western world. A fundamental tool for detection and prevention is the colonoscopy. The detection and endoscopic resection of colorectal polyps, the precursor lesion of CRC can reduce CRC incidence and mortality. Adenoma detection rate is the most used endoscopic quality indicator. The improvement of this indicator is related to the reduction of postcolonoscopy CRC incidence and mortality.
Colorectal polyp diagnosis is based on endoscopic resection and histological analysis. An accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. The NICE international classification has proposed the use of high definition endoscopes that have Narrow Band Imaging. However, NICE must be used by endoscopists who are sufficiently prepared and who have overcome the learning curve. Therefore, optical histology diagnosis with high accuracy independently of the center and the endoscopist is necessary.
Computer Aid Diagnosis (CAD) systems based on Artificial Intelligence are experiencing exponential development in the field of medical image analysis. The development of the CAD system is based on the creation of large databases of endoscopic images and/or videos, on the training, development and validation of diagnostic algorithms in such databases and, finally, on prospective clinical validation in patients undergoing colonoscopy. The goal of CAD systems in colonoscopy is double. First, it aims to increase the detection of polyps (CADe) in general, and of adenomas and serrated lesions in particular. The second objective is to characterize (CADx) the histology of detected lesion.
Polydeep CAD is a functional prototype. It is capable of detecting, locating and classifying colorectal polyps. In vivo validation data shows that Polydeep has high diagnostic accuracy for polyp identification and that this accuracy can be accommodated. The aim of Polydeep advance 1 is to perform the clinical validation within a diagnostic test trial with a paired study design. We will compare the sensitivity of Polydeep to endoscopists blinded to Polydeep in high definition colonoscopy.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 205 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Fundacin Biomedica Galicia Sur is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Both diagnostic interventions will be performed in all patients: High definition colonoscopy and Polydeep system.
Diagnostic Test: Sensitivity of Polydeep vs high experienced endoscopists for colorectal polyp detection
Both diagnostic interventions will be performed in all patients 1. High definition colonoscopy performed by high experienced endoscopists blinded to Polydeep. 2. Polydeep: a CADe and CADx system. The gold standard will be the histological diagnosis of the lesion.
Sensitivity of polydeep vs high experienced endoscopist blinded to polydeep
To compare the sensitivity of Polydeep to a high experienced endoscopist for colorectal polyp detection (adenoma or serrated lesion histologically confirmed)
Time frame: 1 year
Sensitivity for serrated lesions detection.
To compare the sensitivity of Polydeep to a high experienced endoscopist for serrated lesions detection
Time frame: 1 year
Sensitivity for adenoma detection.
To compare the sensitivity of Polydeep to a high experienced endoscopist for adenoma detection
Time frame: 1 year
Sensitivity for advanced colonic lesions
To compare the sensitivity of Polydeep to a high experienced endoscopist for advanced colonic lesions (serrated lesions ≥10mm and/or dysplasia, adenoma ≥10mm and/or villous histology and/or high grade dysplasia) detection
Time frame: 1 year
Sensitivity for diminute lesions (≤5mm)
To compare the sensitivity of Polydeep to a high experienced endoscopist for diminute lesions (≤5mm) detection
Time frame: 1 year
To compare the diagnostic yield of the optical diagnosis
To compare diagnostic yield of optic diagnostic of polydeep to high experienced endoscopists.
Time frame: 1 year
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Fundacin Biomedica Galicia Sur