Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543862
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Autonomous Artificial Intelligence Versus AI Assisted Human Optical Diagnosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Autonomous Artificial Intelligence Versus AI Assisted Human Optical Diagnosis of Colorectal Polyps A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CADx-RCT
Brief Summary:
Computer-aided image-enhanced endoscopy can predict the nature of colorectal polyps with over 90 accuracy This technology uses artificial intelligence AI to analyze video recordings of polyps learning to make diagnoses in real-time This means that doctors can get immediate predictions about small polyps during the procedure reducing the need for separate pathology exams and saving costs ultimately improving patient care
Traditionally non-computer-aided diagnosis of polyps varies greatly between doctors AI can help reduce this variability by providing consistent and accurate computer-aided diagnoses CADx In the past CADx systems could only tell if polyps were cancerous or not However recent advancements show that current CADx systems are as accurate as doctors For widespread use these systems need to recognize different types of polyps including serrated ones which are more challenging to identify Newer CADx systems are being developed to recognize these serrated polyps but they still need further validation for autonomous use
Traditionally non-computer-aided diagnosis of polyps varies greatly between doctors AI can help reduce this variability by providing consistent and accurate computer-aided diagnoses CADx In the past CADx systems could only tell if polyps were cancerous or not However recent advancements show that current CADx systems are as accurate as doctors For widespread use these systems need to recognize different types of polyps including serrated ones which are more challenging to identify Newer CADx systems are being developed to recognize these serrated polyps but they still need further validation for autonomous use
Detailed Description:
Our study hypothesis is that autonomous diagnosis using a novel CADx system with serrated polyp recognition is non inferior to when the endoscopist verifies or corrects the CADx diagnosis Our primary objective is to verify whether the accuracy of optical polyp diagnosis made by the autonomous CADx system AI-A is non-inferior to the accuracy of optical polyp diagnosis made by an endoscopist after seeing the real-time CADx diagnosis AI-H This RCT will allow us to determine the potential use of autonomous CADx for real-time optical polyp diagnosis including serrated polyps
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None