Status:
COMPLETED
Clinical vAliDation of ARTificial Intelligence in POlyp Detection
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Nuovo Regina Margherita Hospital, Rome, Italy
Krankenhaus Barmherzige Brüder, Regensburg, Germany
Conditions:
Polyp of Colon
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
This study is an open label, unblinded, non-randomized interventional study, comparing the investigational artificial intelligence tool with the current "gold standard": Data acquisition will be obtai...
Detailed Description
This is an investigator-initiated non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided detection (CADe) tool for colorectal polyp dete...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age ≥40 years
- Referral for screening, surveillance or diagnostic colonoscopy
- Able to give informed consent by the patient or by a legal representative
- Exclusion criteria for study inclusion
- \<40 years old
- Referral for a therapeutic colonoscopy
- Known Lynch syndrome or Familial Adenomatous Polyposis syndrome
- Any contraindication for colonoscopy or biopsies of the colon
- Uncontrolled coagulopathy
- Confirmed diagnosis of inflammatory bowel disease prior to the scheduled colonoscopy
- Short bowel or ileostomy
- Pregnancy
- Exclusion criteria for study analysis
- Colonic inflammation of \> 30cm during colonoscopy
- Incomplete colonoscopy for any reason
- Incomplete recording or technical failure of the artificial intelligence system
Exclusion
Key Trial Info
Start Date :
October 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2022
Estimated Enrollment :
856 Patients enrolled
Trial Details
Trial ID
NCT04442607
Start Date
October 13 2020
End Date
November 29 2022
Last Update
November 30 2022
Active Locations (1)
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1
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000