A Multi-center Control Study to Determine the Efficacy of CADEYE in Detecting Colon Polyps in Comparison to Standard of Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,000
- Locations
- 2
- Primary Endpoint
- Adenoma detection rate
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •40-80 years old subjects
- •Subjects undergoing colonoscopy for the following: o Primary CRC screening
- •Post-polypectomy surveillance
- •Work up following FIT positivity
- •Symptoms/signs suspicions of CRC
- •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:
- •History of colon resection
- •History of CRC
- •Antithrombotic therapy precluding colon resection o Inflammatory Bowel Disease (IBD)
- •Familial Adenomatous Polyposis (FAP)
- •Pregnant or lactating
- •Poor bowel preparation: BBPS 0 or 1 in a segment
Outcomes
Primary Outcomes
Adenoma detection rate
Time Frame: 1 year
Adenoma detection rate is the primary end point which is the percentage of patients with at least 1 histologically proven adenoma or carcinoma.
Secondary Outcomes
- Proximal Adenoma detection rate(1 year)
- Withdrawal time(1 year)
- Non-neoplastic detection rate(1 year)
- Adenomas detected per colonoscopy(1 year)
Investigators
Mostafa Ibrahim
Mostafa Ibrahim
Theodor Bilharz Research Institute