Status:
NOT_YET_RECRUITING
A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided Diagnosis (CADx) System in Real-time Characterization of Colorectal Neoplasia
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
University College, London
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
The investigators hypothesize that a newly developed CADx system will have a higher diagnostic accuracy in predicting histopathology of colorectal neoplasia than both expert and junior endoscopists.
Detailed Description
Accurate diagnosis and characterization of colorectal polyps is essential before endoscopic resection. Optical diagnosis by enhanced imaging modality (e.g. Narrow Band Imaging, NBI) allows real-time p...
Eligibility Criteria
Inclusion
- They have received colonoscopy for screening, surveillance or symptom investigation;
- They have endoscopic images and videos captured and stored during colonoscopy which are available to be retrieved;
- They have histologically proven colorectal neoplasia.
- Written consent obtained
Exclusion
- Poor quality endoscopic images and videos defined as:
- Incomplete visualization of the colorectal neoplasia due to technical reasons (e.g. out-of-focus, motion-blurred or insufficient illumination);
- Artifacts due to mucus, air bubbles, stool, or blood.
- Active gastrointestinal bleeding;
- Fulminant colitis;
- Obscured view due to poor bowel preparation;
- Artificial staining of lesion due to chromoendoscopy.
- Unable to obtain informed consent
Key Trial Info
Start Date :
December 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT05414383
Start Date
December 1 2024
End Date
December 31 2025
Last Update
February 9 2024
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