Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.
NCT Number: NCT06568523
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Screening Colonoscopy|Surveillance Colonoscopy
Interventions: DIAGNOSTIC_TEST: MAGENTIQ-COLO.
Sponsor: Magentiq Eye LTD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 330
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-09-15
Completion Date: 2025-08-31
Locations: Johns Hopkins Hospital, Baltimore, Maryland, 21202, United States|Erlanger Health System, Chattanooga, Tennessee, 37403, United States|Assuta, Haifa, Select State, Israel|Hadassah Medical Organization, Jerusalem, 91120, Israel|Erasmus Medical Center, Rotterdam, 3000 CA, Netherlands

Summary:
This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.

Primary Outcome Measures: The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the reference gold standard., The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (\>5mm) compared to the reference gold standard, which is the size classification of the colorectal polyp using open biopsy forceps, or polypectomy snare, of known diameter.

The diagnostic performance of the CADx-assisted optical diagnosis to correctly classify colorectal polyps as diminutive (≤5mm) or non-diminutive (\>5mm) compared to size classification using open biopsy forceps, or polypectomy snare, of known diameter. This will be measured by the sensitivity and specificity of the CADx-assisted optical diagnosis compared to an expected minimum of 70% sensitivity and 70% specificity., During the Colonoscopy Procedure
Secondary Outcome Measures: CADx size measurement vs. open biopsy forceps, The diagnostic performance of the optical diagnosis of the CADx system for correctly classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (\>5mm) compared to the size classification using open biopsy forceps, or polypectomy snare, of known diameter. This will be measured by the sensitivity, specificity, and accuracy of the CADx-assisted optical diagnosis.

In addition, the correlation between the size measurement in millimeters by the CADx system and by using open biopsy forceps or polypectomy snare of known diameter will be calculated. This correlation will also be conducted for classifying polyps into diminutive (≤5mm), small (6-9mm), and advanced (≥10mm) size categories., During the Colonoscopy Procedure|ESGE 'resect-and-discard' & 'leave-in-situ', The diagnostic performance of high-confidence CADx-assisted optical diagnosis to correctly identify diminutive colorectal polyps as neoplastic (adenoma or SSL). This will be measured by the sensitivity and specificity of the high-confidence CADx-assisted optical diagnosis compared to the ESGE 'resect-and-discard' strategy; an expected minimum of 80% sensitivity and 80% specificity. Additionally, for diminutive polyps located in the rectosigmoid, the diagnostic performance will be compared to the ESGE 'leave-in-situ' strategy, with an expected minimum sensitivity of 90% and specificity of 80% for neoplastic diagnosis, During the Colonoscopy Procedure
Other Outcome Measures: ASGE PIVI-1 Post-polypectomy surveillance interval, The ability of the CADx-assisted optical diagnosis to correctly assign post-polypectomy surveillance intervals. This will be measured by the agreement rate of high-confidence CADx-assisted optical diagnosis for polyps ≤5mm (cutoff based on the reference gold standard of this study) combined with the pathological diagnosis for polyps \>5mm compared to the ASGE PIVI-1 criteria; an expected minimum of 90% agreement between assigning ASGE/US Multisociety Task Force on Colorectal Cancer (USMSTF) post-polypectomy surveillance intervals, During the Colonoscopy Procedure|ASGE PIVI-2 NPV of neoplastic rectosigmoid polyps, The diagnostic performance of CADx-assisted optical diagnosis to correctly identify diminutive polyps in the rectosigmoid as neoplastic. This will be measured by the negative predictive value (NPV) of the high-confidence CADx-assisted optical diagnosis compared to the ASGE PIVI-2 criteria; an expected minimum of 90% NPV, During the Colonoscopy Procedure|Rate of high-confidence diagnoses, The rate of high-confidence neoplastic diagnoses (size and optical diagnosis) of diminutive colorectal polyps between standard visual inspection, the CADx system diagnosis, and CADx-assisted optical diagnosis., During the Colonoscopy Procedure