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Trial Title:
A Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care (White Light )
NCT ID:
NCT05523271
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal Cancer screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Participant)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
CAD EYE (Computer Aided Diagnosis ----?
Description:
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.
Arm group label:
Patients undergoing CAD EYE endoscopy
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
40 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Theodor Bilharz Research Institute
Address:
City:
Giza
Zip:
12311
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Mostafa Ibrahim, MD
Phone:
00201006107100
Email:
mostafa.ibrahim@webgit.net
Investigator:
Last name:
Mostafa Ibrahim, MD
Email:
Principal Investigator
Start date:
January 16, 2023
Completion date:
August 30, 2023
Lead sponsor:
Agency:
Theodor Bilharz Research Institute
Agency class:
Other
Source:
Theodor Bilharz Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05523271
