Primary completion date2024-08-15→2024-11-15
Completion date2024-08-15→2024-11-15
Start date2024-08-15→2024-11-15
Enrollment target400→540
Study arms2→1
Eligibility criteria+145 characters
Inclusion Criteria:
Indication for full colonoscopy.
Exclusion Criteria:
Known inflammatory bowel disease
Active colitis
coagulopathy
familial polyposis syndrome
poor general health, defined as an American Society of Anesthesiologists class >3
emergency colonoscopy
Secondary endpoints5 to 6 entries
Accuracy of optical diagnosis, for polyps 1-10mm, compared with an agreed upon CADx-assisted diagnosis
Primary endpoints1 entry, revised
Accuracy of autonomous CADx system (AI-A) optical diagnosis, for polyps 1-5mm, compared with thean real-timeagreed upon CADx-assisted diagnosis (AI-H)
Study description-20 characters
Our study hypothesis is that autonomousfor diagnosisCADx implementation, instead of using athe novelhigh/low confidence framework, identifying cases with suboptimal diagnostic accuracy could be facilitated through identifying cases in which CADx systemand endoscopist disagreed in their diagnosis.
Eliminating such cases might separate out cases with low accuracy when using CADx assisted OD.
Since endoscopists have a high sensitivity but low specificity for serrated polyp recognitionOD, isthis non inferior to when the endoscopist verifies or corrects the CADx diagnosis.
Our primary objective is [...] [...]
Collaborators-48 characters
Roupen Djinbachian, MD
Mahsa Taghiakbari, MD PHD