Back to resultsA Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care (White Light )
Primary Purpose
Colorectal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CAD EYE (Computer Aided Diagnosis ----?
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colorectal Cancer screening
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
Sites / Locations
- Theodor Bilharz Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Patients undergoing White Light Endoscopy (standard of care)
Patients undergoing CAD EYE endoscopy
Arm Description
All subjects in Experimental Arm A will undergo SOC (white-light endoscopy).
All subjects in Experimental Arm B will undergo CADEYE endoscopy.
Outcomes
Primary Outcome Measures
Adenoma detection rate
Adenoma detection rate is the primary end point which is the percentage of patients with at least 1 histologically proven adenoma or carcinoma.
Secondary Outcome Measures
Adenomas detected per colonoscopy
Proximal Adenoma detection rate
Withdrawal time
Non-neoplastic detection rate
Full Information
NCT ID
NCT05523271
First Posted
August 29, 2022
Last Updated
January 16, 2023
Sponsor
Theodor Bilharz Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05523271
Brief Title
A Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care (White Light )
Official Title
A Multi-center Control Study to Determine the Efficacy of CADEYE in Detecting Colon Polyps in Comparison to Standard of Care
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Theodor Bilharz Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer screening
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing White Light Endoscopy (standard of care)
Arm Type
No Intervention
Arm Description
All subjects in Experimental Arm A will undergo SOC (white-light endoscopy).
Arm Title
Patients undergoing CAD EYE endoscopy
Arm Type
Experimental
Arm Description
All subjects in Experimental Arm B will undergo CADEYE endoscopy.
Intervention Type
Diagnostic Test
Intervention Name(s)
CAD EYE (Computer Aided Diagnosis ----?
Intervention 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.
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
Adenoma detection rate is the primary end point which is the percentage of patients with at least 1 histologically proven adenoma or carcinoma.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adenomas detected per colonoscopy
Time Frame
1 year
Title
Proximal Adenoma detection rate
Time Frame
1 year
Title
Withdrawal time
Time Frame
1 year
Title
Non-neoplastic detection rate
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Ibrahim, M.D PhD
Phone
01006107100
Email
mostafa.ibrahim@webgit.net
First Name & Middle Initial & Last Name or Official Title & Degree
Farah Ebrahim, Medicine
Phone
01066443936
Email
Farah.Ahmed@roeyaegypt.com
Facility Information:
Facility Name
Theodor Bilharz Research Institute
City
Giza
ZIP/Postal Code
12311
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa Ibrahim, MD
Phone
00201006107100
Email
mostafa.ibrahim@webgit.net
First Name & Middle Initial & Last Name & Degree
Mostafa Ibrahim, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care (White Light )
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