A Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care (White Light )

A Multi-center Control Study to Determine the Efficacy of CADEYE in Detecting Colon Polyps in Comparison to Standard of Care

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Diagnostic test: CAD EYE (Computer Aided Diagnosis ----?

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 Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mostafa Ibrahim, M.D PhD; Phone Number: 01006107100; Email: mostafa.ibrahim@webgit.net
• Study Contact Backup: Name: Farah Ebrahim, Medicine; Phone Number: 01066443936; Email: Farah.Ahmed@roeyaegypt.com

Study Locations

• Egypt
  • Giza, Egypt, 12311
    • Recruiting
    • Theodor Bilharz Research Institute
    • Contact: Mostafa Ibrahim, MD; Phone Number: 00201006107100; Email: mostafa.ibrahim@webgit.net
    • Principal Investigator: Mostafa Ibrahim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Patients undergoing White Light Endoscopy (standard of care); All subjects in Experimental Arm A will undergo SOC (white-light endoscopy).
Experimental: Patients undergoing CAD EYE endoscopy; All subjects in Experimental Arm B will undergo CADEYE endoscopy.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Adenomas detected per colonoscopy	1 year
Proximal Adenoma detection rate	1 year
Withdrawal time	1 year
Non-neoplastic detection rate	1 year

Collaborators and Investigators

• Sponsor: Theodor Bilharz Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Anticipated): August 30, 2023
• Study Completion (Anticipated): August 30, 2023

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Colorectal Cancer screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CADEYE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No