Viewing Study NCT04777019



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Last Modification Date: 2024-10-26 @ 1:58 PM
Study NCT ID: NCT04777019
Status: RECRUITING
Last Update Posted: 2022-05-18
First Post: 2021-02-02

Brief Title: Computer Aided Polyp Detection C3PO Trial
Sponsor: The University of Texas Health Science Center Houston
Organization: The University of Texas Health Science Center Houston

Study Overview

Official Title: Computer Aided Polyp Detection C3PO Trial A Multicenter International Trial Evaluating Diagnostic Accuracy of Artificial Intelligence System in Detecting Colon Polyps
Status: RECRUITING
Status Verified Date: 2022-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Computer aided detection CADe algorithms have been developed to overcome human errors and assist endoscopists in detecting more polyps during colonoscopy The aim of this study was 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 from two different institutes
Detailed Description: 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None