NCT06059378 Using AI-assisted Optical Polyp Diagnosis for Diminutive Colorectal Polyps
| NCT ID | NCT06059378 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Daniel Von Renteln |
| Condition | Artificial Intelligence |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2025-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 204 participants in total. It began in 2023-09-01 with a primary completion date of 2025-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age 45-80 years * Undergoing an outpatient colonoscopy at the Centre Hospitalier de l'Université de Montréal (CHUM) * Signed informed consent form Exclusion Criteria: * Inflammatory Bowel Disease; * Active colitis; * Hereditary CRC syndrome; * Coagulopathy; * American Society of Anesthesiologists (ASA) status \>3
Contact & Investigator
Daniel von Renteln, MD
PRINCIPAL INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Frequently Asked Questions
Who can join the NCT06059378 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 80 Years, studying Artificial Intelligence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06059378 currently recruiting?
Yes, NCT06059378 is actively recruiting participants. Visit ClinicalTrials.gov or contact Daniel Von Renteln to inquire about joining.
Where is the NCT06059378 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT06059378 clinical trial?
NCT06059378 is sponsored by Daniel Von Renteln. The principal investigator is Daniel von Renteln, MD at Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 204 participants.