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

S

Shanghai Jiao Tong University School of Medicine

Status

Completed

Conditions

Advanced Adenoma

Treatments

Device: AI system of optical detection of advanced adenomas

Study type

Interventional

Funder types

Other

Identifiers

NCT05568992
Renji KY[2019]009

Details and patient eligibility

About

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

Full 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.

Enrollment

120 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Endoscopists with NBI experience

Exclusion criteria

  • Endoscopists without colonoscopy and NBI experience

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

AI assisted group
Experimental group
Description:
AI assisted endoscopist' optical detection of advanced adenomas among 100 images of polyps
Treatment:
Device: AI system of optical detection of advanced adenomas
non-AI assisted group
No Intervention group
Description:
Endoscopist' optical detection of advanced adenomas among 100 images of polyps using their experience of colonoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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