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

Primary Purpose

Advanced Adenoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AI system of optical detection of advanced adenomas
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Advanced Adenoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Endoscopists with NBI experience

Exclusion Criteria:

  • Endoscopists without colonoscopy and NBI experience

Sites / Locations

  • Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AI assisted group

non-AI assisted group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of advanced adenomas for sending to histological examination
Proportion of advanced adenomas for sending to histological examination

Secondary Outcome Measures

Optical diagnostic accuracy of non-advanced adenomas under high confidence
Optical diagnostic accuracy of non-advanced adenomas under high confidence
Proportion of high confidence optical diagnosis of polyps
Proportion of high confidence optical diagnosis of polyps

Full Information

First Posted
October 3, 2022
Last Updated
October 14, 2022
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05568992
Brief Title
Prospective, Randomized Controlled Study to Evaluate the Effect of Artificial Intelligence Assisted Optical Diagnosis of Advanced Adenomas
Official Title
Prospective, Randomized Controlled Study to Evaluate the Effect of Artificial Intelligence Assisted Optical Diagnosis of Advanced Adenomas
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
October 9, 2022 (Actual)
Study Completion Date
October 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Adenoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AI assisted group
Arm Type
Experimental
Arm Description
AI assisted endoscopist' optical detection of advanced adenomas among 100 images of polyps
Arm Title
non-AI assisted group
Arm Type
No Intervention
Arm Description
Endoscopist' optical detection of advanced adenomas among 100 images of polyps using their experience of colonoscopy
Intervention Type
Device
Intervention Name(s)
AI system of optical detection of advanced adenomas
Intervention Description
AI system of optical detection of advanced adenomas
Primary Outcome Measure Information:
Title
Proportion of advanced adenomas for sending to histological examination
Description
Proportion of advanced adenomas for sending to histological examination
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Optical diagnostic accuracy of non-advanced adenomas under high confidence
Description
Optical diagnostic accuracy of non-advanced adenomas under high confidence
Time Frame
1 day
Title
Proportion of high confidence optical diagnosis of polyps
Description
Proportion of high confidence optical diagnosis of polyps
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Endoscopists with NBI experience Exclusion Criteria: Endoscopists without colonoscopy and NBI experience
Facility Information:
Facility Name
Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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