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This study is to assess the sensitivity and added benefits of CADEYE compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.
Full description
Failure in polyp recognition is a major determinant for the high rate of missed colorectal neoplasms. In response, technological advances have paved the way for Computer-Aided Polyp Detection (CAD-e) systems. Artificial intelligence systems allow of real-time computer- aided detection of polyps with high-accuracy. CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure.
The data generated from this study will provide an estimate of the ADR throughout the Middle East as well as assess the accuracy of CADEYE in detecting adenomas in comparison to standard of care.
Enrollment
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Volunteers
Inclusion criteria
40-80 years old subjects
Subjects undergoing colonoscopy for the following: o Primary CRC screening
Subjects must be willing to give written informed consent for the trial
Exclusion criteria
Unable to consent
Contraindicated to undergo endoscopy
Hospitalized patient
Patients with the following conditions:
Pregnant or lactating
Poor bowel preparation: BBPS 0 or 1 in a segment
Primary purpose
Allocation
Interventional model
Masking
1,000 participants in 2 patient groups
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Central trial contact
Mostafa Ibrahim, M.D PhD; Farah Ebrahim, Medicine
Data sourced from clinicaltrials.gov
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