A Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care (White Light )
NCT ID: NCT05523271
Last Updated: 2023-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2023-01-16
2023-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Patients undergoing White Light Endoscopy (standard of care)
All subjects in Experimental Arm A will undergo SOC (white-light endoscopy).
No interventions assigned to this group
Patients undergoing CAD EYE endoscopy
All subjects in Experimental Arm B will undergo CADEYE endoscopy.
CAD EYE (Computer Aided Diagnosis ----?
CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure and and allows a real time computer aided detection of polyps with high accuracy.
Interventions
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CAD EYE (Computer Aided Diagnosis ----?
CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure and and allows a real time computer aided detection of polyps with high accuracy.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
Yes
Sponsors
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Theodor Bilharz Research Institute
OTHER
Responsible Party
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Mostafa Ibrahim
Mostafa Ibrahim
Locations
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Theodor Bilharz Research Institute
Giza, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CADEYE
Identifier Type: -
Identifier Source: org_study_id
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