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

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT05568992

Collaborator

(none)

120

Enrollment

Location

Arms

Actual Duration (Days)

456.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Adenoma	Device: AI system of optical detection of advanced adenomas	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 6, 2022

Actual Primary Completion Date :

Oct 9, 2022

Actual Study Completion Date :

Oct 14, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: AI assisted group

AI assisted endoscopist' optical detection of advanced adenomas among 100 images of polyps

Device: AI system of optical detection of advanced adenomas

AI system of optical detection of advanced adenomas

No Intervention: non-AI assisted group

Endoscopist' optical detection of advanced adenomas among 100 images of polyps using their experience of colonoscopy

Outcome Measures

Primary Outcome Measures

Proportion of advanced adenomas for sending to histological examination [1 day]
Proportion of advanced adenomas for sending to histological examination

Secondary Outcome Measures

Optical diagnostic accuracy of non-advanced adenomas under high confidence [1 day]
Optical diagnostic accuracy of non-advanced adenomas under high confidence
Proportion of high confidence optical diagnosis of polyps [1 day]
Proportion of high confidence optical diagnosis of polyps

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Endoscopists with NBI experience

Exclusion Criteria:

Endoscopists without colonoscopy and NBI experience

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai		China	200001

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaobo Li, Chief physician, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT05568992

Other Study ID Numbers:

Renji KY[2019]009

First Posted:

Oct 6, 2022

Last Update Posted:

Oct 18, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenoma

Study Results

No Results Posted as of Oct 18, 2022