Artificial Intelligence Identifying Polyps in Real-world Colonoscopy
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|ClinicalTrials.gov Identifier: NCT03761771|
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : December 4, 2018
|Condition or disease||Intervention/treatment|
|Sensitivity of the ADS in Identifying Polyps in Real-world Colonoscopy||Device: colonoscopy withdrawal with the ADS monitoring|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Validating the Performance of Artificial Intelligence in Identifying Polyps in Real-world Colonoscopy|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||December 30, 2018|
|Estimated Study Completion Date :||December 30, 2018|
colonoscopy withdrawal with the ADS monitoring
The ADS automatically initiated once the ileocecal valve was pictured by the colonoscopist or the colonoscopist recorded any image of colon during the insertion. When colonoscopists withdrew the colonoscopies and inspect the colons, the video streaming of colonoscopies was real-time switched to the ADS, which made it feasible to identify and classify lesions in real time.
Device: colonoscopy withdrawal with the ADS monitoring
During the testing of trained ADS, when the system doubts colonic lesions from the input data of the test images, a rectangular frame was displayed in the endoscopic image to surround the lesion. If the system confirmed it as the colonic lesions, a sound of reminder will be played and the types of lesions (non-adenomatous polyps, adenomatous polyps and colorectal cancers) will be classified by the system. We adopted several standards to define the identification and classification of colonic lesions: 1) when the system identified and confirmed any lesion in the images of no polyps or cancers, the results were judged to be false-positive. 2) when the system both confirmed and correctly localized the lesions in images (IoU > 0.3), the results were judged to be true-positive. 3) when the system did not confirm or correctly localize the lesions, the results were judged as false-negative. 4) when system confirmed no lesions in the normal images, the results were judged to be true-negative.
- sensitivity of the ADS in identifying polyps [ Time Frame: 1 hour ]Polyps that were only reported by colonoscopists were considered to be missed by the ADS (polyps were reported by the colonoscopists and the ADS did not identify the location of polyps until colonoscopists unfolded and pictured the polyps.)
- false positves of the ADS per colonoscopy withdrawal [ Time Frame: 1 hour ]when the system identified and confirmed any lesion in the images with no polyps or cancers appearing, the results were judged to be false-positive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761771
|Contact: Li Zhaoshen, MDemail@example.com|
|Contact: Bai Yu, MDfirstname.lastname@example.org|
|Changhai Hospital, Second Military Medical University||Recruiting|
|Shanghai, China, 200433|
|Contact: zhaoshen Li, MD 86-21-81873241 email@example.com|
|Principal Investigator: zhaoshen Li, MD|
|Shanghai, China, 200433|
|Contact: Zhaoshen Li, MD|