Computer Aided Polyp Detection (C3PO) Trial
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|ClinicalTrials.gov Identifier: NCT04777019|
Recruitment Status : Recruiting
First Posted : March 2, 2021
Last Update Posted : March 2, 2021
|Condition or disease||Intervention/treatment|
|Colonic Polyp||Other: Not applicable as standard of care Colonoscopy|
Details regarding polyp size and location, morphology including Paris classification, optical assessment, and bowel preparation were prospectively collected and recorded in the online Redcap software. Final results of polyp histology were also collected. The video library was then independently reviewed for quality assessment by 3 experienced gastroenterologists. Videos that passed the initial quality assessment were then independently evaluated using the Discovery-AI system.
Aim of the study was to evaluate overall performance of Discovery-AI system for polyps of various size, morphology and pathology utilizing a prospectively developed video library.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Computer Aided Polyp Detection (C3PO) Trial: A Multicenter International Trial Evaluating Diagnostic Accuracy of Artificial Intelligence System in Detecting Colon Polyps|
|Actual Study Start Date :||June 7, 2020|
|Estimated Primary Completion Date :||June 7, 2023|
|Estimated Study Completion Date :||June 6, 2025|
- Other: Not applicable as standard of care Colonoscopy
Not applicable since not an intervention
- To investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls [ Time Frame: 3 years ]The video library was developed during screening and surveillance colonoscopy and included details on polyp size, location, morphology, overall Boston bowel preparation score (BBPS) and segmental BBPS. Each video segments ranged from 35 seconds to 75 seconds. Before inclusion, each video was evaluated by 3 expert endoscopists individually to assess overall quality of the video. Quality of video was assessed based on pixel resolution and aspect ratio, bowel preparation, overall speed of withdrawal, colon distension, and adequate mucosal exposure. If the video was deemed of adequate quality by at least 2 endoscopists, it was included in the study cohort.
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): NCT04777019
|Contact: Prithvi B Patil, MSfirstname.lastname@example.org|
|Contact: Nirav Thosani, MD, MHAemail@example.com|
|United States, Texas|
|Memorial Hermann Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Prithvi B Patil 713-480-1179 firstname.lastname@example.org|
|Contact: Prithvi Patil, MS 7135006456 email@example.com|
|Principal Investigator: Nirav Thosani, MD,MHA|