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
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Jan 2023
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2022
CompletedFirst Posted
Study publicly available on registry
August 31, 2022
CompletedStudy Start
First participant enrolled
January 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedJanuary 19, 2023
January 1, 2023
8 months
August 29, 2022
January 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Adenomas detected per colonoscopy
1 year
Proximal Adenoma detection rate
1 year
Withdrawal time
1 year
Non-neoplastic detection rate
1 year
Study Arms (2)
Patients undergoing White Light Endoscopy (standard of care)
NO INTERVENTIONAll subjects in Experimental Arm A will undergo SOC (white-light endoscopy).
Patients undergoing CAD EYE endoscopy
EXPERIMENTALAll subjects in Experimental Arm B will undergo CADEYE endoscopy.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Theodor Bilharz Research Institute
Giza, 12311, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mostafa Ibrahim
Study Record Dates
First Submitted
August 29, 2022
First Posted
August 31, 2022
Study Start
January 16, 2023
Primary Completion
August 30, 2023
Study Completion
August 30, 2023
Last Updated
January 19, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share