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Using AI-assisted Optical Polyp Diagnosis for Diminutive Colorectal Polyps

Study acronym: AI-OD
StatusActive, Not Recruiting
PhaseNot applicable
Started2023-09-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-22
Enrollment closed, study ongoing
Sponsor changed: Daniel Von Renteln → Centre hospitalier de l'Université de Montréal (CHUM)+35 characters
WasDaniel Von Renteln
NowCentre hospitalier de l'Université de Montréal (CHUM)
Completion pushed: 2025-06-30 → 2027-08-31
2025-02-14
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures v2
Primary completion date2023-12-01→2025-05-01
Completion date2024-01-30→2025-06-30
Enrollment target102→204
Study arms1→2
Secondary endpoints6 entries, revised
Proportion of patients who accept study participation Proportion of the patients unwilling to participate due to concerns regarding undergoing an optical diagnosis Agreement between the intracolonoscopy AI-assisted optical diagnosis and the AI-assisted optical diagnosis by experts Diagnostic characteristics of of (CADx) AI-assisted optical diagnosis strategy using adjudication by two expert endoscopists as the reference standard Negative predictive value for the diagnosisProportion of rectosigmoidpolyps adenomaswith ofa an AI (CADx) assisted opticallow-confidence diagnosis (diagnose and leave) [...]
Primary endpoints1 entry, revised
AgreementAccuracy betweenof (CADx)the intracolonoscopy AI-assisted optical diagnosis and adjudication by two expert endoscopists in establishing surveillance intervals
Study description+776 characters
All patients who meet the in/exclusioninclusion criteria can be enrolled. Eligible patients will be informe [...] esect and discard, diagnose and leave) and AI/CADx systems. We will ask the patients' willingness to undergo AI-assisted optical diagnosis with endoscopists' input (the first 102 patients) and automomous AI-assisted optical diagnosis (from patient 103 to 204). Subsequently, patients will be asked if they are willing to [...] eral. Other reasons. Preference not to answer the question. This data along with patient characteristics (age, sex) will be captured and kept to analyse reasons for non-par [...] [...]
Study title+17 characters
Real-life Implementation of anUsing AI-basedassisted Optical Polyp Diagnosis for Diminutive Colorectal Polyps
2023-09-28
Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions v1
Enrollment target226→102
Lead sponsorCentre hospitalier de l'Université de Montréal (CHUM)→Daniel Von Renteln
2023-09-22
Original filing
This is a prospective study that is the first to implement resect and discard and diagnose and leave strategies in real-time practice using stringent documentation and adjudication by 2 expert endoscopists as the gold standard. The primary aim of this study is to show the accuracy of intracolonoscopy AI-assisted optical diagnosis (CADx; autonomous or with human input) when the AI-assisted optical diagnosis made by the expert endoscopists is used as the reference standard. The specific aims are: 1. To evaluate the accuracy of intracolonoscopy AI-assisted optical polyp diagnosis (autonomous or with human input) by comparing it to the obtained optical histology diagnoses provided by two independent expert endoscopists as the reference standard. 2. To evaluate the agreement between the intracolonoscopy AI-assisted optical polyp diagnosis (autonomous or with human input) and the AI-assisted optical diagnosis performed by two independent expert endoscopists. 3. To determine whether AI-assisted optical polyp diagnosis for diminutive (1-5 mm) polyps can be implemented in routine clinical practice by demonstrating that at least 70% of the approached patients are interested in undergoing AI-assisted optical diagnosis (autonomous or with human input). 4. To evaluate the cost savings resulting from replacing pathology with AI-assisted optical diagnosis.
Trial Details
NCT Number NCT06059378
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Conditions Artificial Intelligence
Enrollment 204 participants
Start Date 2023-09-01
Primary Completion 2025-05-01 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-21