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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Diagnostic Test: CAD EYE (Computer Aided Diagnosis ----?

• Registration Number: NCT05523271
• Lead Sponsor: Theodor Bilharz Research Institute

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.

Study Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Status Verified: 2023-01
• Study Start: 2023-01-16
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-19
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients undergoing CAD EYE endoscopy	CAD EYE (Computer Aided Diagnosis ----?	All subjects in Experimental Arm B will undergo CADEYE endoscopy.

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	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.

Secondary Outcome Measures

Name	Time	Method
Proximal Adenoma detection rate	1 year
Withdrawal time	1 year
Non-neoplastic detection rate	1 year
Adenomas detected per colonoscopy	1 year

Trial Locations

Locations (1)

Theodor Bilharz Research Institute; 🇪🇬 Giza, Egypt