Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT06753318
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-31
First Post:
2024-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of Joint-AI in Diagnosing Pancreatic Solid Lesions
Sponsor:
Huazhong University of Science and Technology
Organization:
Study Overview
Official Title:
Validation of a Multimodal Artificial Intelligence Model in in Diagnosing Pancreatic Solid Lesions: a Prospective, Multicenter, Randomized, Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-12
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:
This clinical trial aims to learn if a multimodal artificial intelligence (AI) model can enhance the diagnosis of pancreatic solid lesions. The main questions it aims to answer are:
1. Does the AI model enhance the diagnostic performance of endoscopists in diagnosing pancreatic solid lesions?
2. Does the addition of interpretability analysis further improve the diagnostic performance of the assisted endoscopists? Researchers will compare the diagnostic performance of endoscopists with or without the assistance of the AI model.
Participants will:
1. Their clinical data will be prospectively collected.
2. They will be randomized to the AI-assist group and the conventional diagnosis group.
1. Does the AI model enhance the diagnostic performance of endoscopists in diagnosing pancreatic solid lesions?
2. Does the addition of interpretability analysis further improve the diagnostic performance of the assisted endoscopists? Researchers will compare the diagnostic performance of endoscopists with or without the assistance of the AI model.
Participants will:
1. Their clinical data will be prospectively collected.
2. They will be randomized to the AI-assist group and the conventional diagnosis group.
Detailed Description:
The investigators have previously developed a multimodal AI model (Joint-AI) based on endoscopic ultrasound images and clinical data to diagnose pancreatic solid lesions. This study aims to improve the Joint-AI model's performance with a prospectively collected dataset and validate it through a randomized controlled clinical trial.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: