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

Theodor Bilharz Research Institute

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Diagnostic Test: CAD EYE (Computer Aided Diagnosis ----?

Study type: Interventional

Funder types: Other

Identifiers

NCT05523271

CADEYE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

Patients undergoing White Light Endoscopy (standard of care)

No Intervention group

Description:

All subjects in Experimental Arm A will undergo SOC (white-light endoscopy).

Patients undergoing CAD EYE endoscopy

Experimental group

Description:

All subjects in Experimental Arm B will undergo CADEYE endoscopy.

Treatment:

Diagnostic Test: CAD EYE (Computer Aided Diagnosis ----?