Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorMagentiq Eye LTD
About this trial
This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals aged ≥45 - ≤80 years old, who are scheduled for non-iFOBT screening or surveillance colonoscopy.
Disqualifiers
In situ polyps with known histology detected in a previous colonoscopy.
No colorectal polyps detected during colonoscopy.
Known or suspected inflammatory bowel disease.
Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis).
Trial design
Design model
Single group
Treatments tested in this trial
MAGENTIQ-COLO.
Diagnostic testThis is a diagnostic performance study; no randomization will be conducted. All subjects will undergo the same study procedures. The endoscopist performing the examinations cannot be blinded for the output of the investigational device in this study. Due to the nature of the intervention, it is not guaranteed that the patient is not awake during the procedure, therefore blinding for the patient is also not feasible.
Treatment groups
330 Participants
are divided into 1 treatment groupGroup A: Patients will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology.Other 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
During the Colonoscopy ProcedureSecondary outcomes
1
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.
Time frame
During the Colonoscopy Procedure2
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
Time frame
During the Colonoscopy ProcedureOther outcomes
1
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
Time frame
During the Colonoscopy Procedure2
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
Time frame
During the Colonoscopy Procedure3
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.
Time frame
During the Colonoscopy ProcedureSponsors and contacts
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Source ClinicalTrials.gov
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