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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05523271
• Other study ID #: CADEYE
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: January 2023
• Source: Theodor Bilharz Research Institute
• Contact: Mostafa Ibrahim, M.D PhD
• Phone: 01006107100
• Email: mostafa.ibrahim[@]webgit.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Egypt	Theodor Bilharz Research Institute	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Theodor Bilharz Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adenomas detected per colonoscopy		1 year
Secondary	Proximal Adenoma detection rate		1 year
Secondary	Withdrawal time		1 year
Secondary	Non-neoplastic detection rate		1 year