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

January 16, 2023 updated by: Mostafa Ibrahim, Theodor Bilharz Research Institute

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt, 12311
        • Recruiting
        • Theodor Bilharz Research Institute
        • Contact:
        • Principal Investigator:
          • Mostafa Ibrahim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theodor Bilharz Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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