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Clinical Trials/NCT05568992
NCT05568992
Completed
Not Applicable

Prospective, Randomized Controlled Study to Evaluate the Effect of Artificial Intelligence Assisted Optical Diagnosis of Advanced Adenomas

Shanghai Jiao Tong University School of Medicine1 site in 1 country120 target enrollmentOctober 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Advanced Adenoma
Sponsor
Shanghai Jiao Tong University School of Medicine
Enrollment
120
Locations
1
Primary Endpoint
Proportion of advanced adenomas for sending to histological examination
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study is a clinical validation of our developed a computer-aided optical dignosis of advanced adenoma using non-magnified NBI image. This study is a randomized clinical trial comparing endoscopists' optical recognition of advanced adenoma for sending to histological examination with our computer-aided system. The hypothesis of the study is that the developed computer-aided system increases the percent of sending actual advanced adenoma Intelligence Assisted Optical Diagnosis of Advanced Adenomas

Detailed Description

Colorectal polyp diagnosis is based on endoscopic resection and histological analysis. An accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. However, it should be noted this policy could only be applied in diminutive polys considering high proposition of advanced adenomas in polyps more than 5 mm. In addition, optical diagnosis criteria of advanced adenomas have not been validated for finding advanced adenomas among adenoma polyps. If as many as advanced adenomas as possible could be differentiated from non-advanced adenomas and be further sent for histological examination, this policy could be generalized to small polyps. Considering this situation, the investigators tried to develop computer-aided optical dignosis of advanced adenoma using non-magnified NBI image with preliminary, satisfied results. In this study, the investigators next validate the investigators' developed computer-aided system for detecting advanced adenomas by comparing endoscopists' optical detection of advanced adenomas with or without the investigators' computer-aided system.

Registry
clinicaltrials.gov
Start Date
October 6, 2022
End Date
October 14, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Jiao Tong University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Xiaobo Li

Chief physician

Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • Endoscopists with NBI experience

Exclusion Criteria

  • Endoscopists without colonoscopy and NBI experience

Outcomes

Primary Outcomes

Proportion of advanced adenomas for sending to histological examination

Time Frame: 1 day

Proportion of advanced adenomas for sending to histological examination

Secondary Outcomes

  • Proportion of high confidence optical diagnosis of polyps(1 day)
  • Optical diagnostic accuracy of non-advanced adenomas under high confidence(1 day)

Study Sites (1)

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