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

NCT05568992 | Completed

• 1 other identifier: Renji KY[2019]009
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Adenoma

Outcome Measures

Primary Outcomes (1)

• Proportion of advanced adenomas for sending to histological examination

  Proportion of advanced adenomas for sending to histological examination

  1 day

Secondary Outcomes (2)

• Optical diagnostic accuracy of non-advanced adenomas under high confidence

  1 day

• Proportion of high confidence optical diagnosis of polyps

  1 day

Study Arms (2)

AI assisted group

EXPERIMENTAL

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

Device: AI system of optical detection of advanced adenomas

non-AI assisted group

NO INTERVENTION

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

Interventions

AI system of optical detection of advanced adenomas DEVICE

AI system of optical detection of advanced adenomas

AI assisted group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endoscopists with NBI experience

You may not qualify if:

• Endoscopists without colonoscopy and NBI experience

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, 200001, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: October 6, 2022
• Primary Completion: October 9, 2022
• Study Completion: October 14, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)