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

Advanced Adenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05568992
• Other study ID #: Renji KY[2019]009
• Status: Completed
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: October 14, 2022

Study information

• Verified date: October 2022
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 14, 2022
• Est. primary completion date: October 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Endoscopists with NBI experience

Exclusion Criteria:

• Endoscopists without colonoscopy and NBI experience

Related Conditions & MeSH terms

• Adenoma
• Advanced Adenoma

Intervention

Device:
• AI system of optical detection of advanced adenomas
AI system of optical detection of advanced adenomas

Locations

Country	Name	City	State
China	Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of advanced adenomas for sending to histological examination	Proportion of advanced adenomas for sending to histological examination	1 day
Secondary	Optical diagnostic accuracy of non-advanced adenomas under high confidence	Optical diagnostic accuracy of non-advanced adenomas under high confidence	1 day
Secondary	Proportion of high confidence optical diagnosis of polyps	Proportion of high confidence optical diagnosis of polyps	1 day