Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335654
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-22
Brief Title:
Real-time Artificial Intelligence-based Endocytoscopic Diagnosis of Colorectal Neoplasms
Sponsor:
The First Hospital of Jilin University
Organization:
The First Hospital of Jilin University
Study Overview
Official Title:
Real-time Artificial Intelligence-based Endocytoscopic Diagnosis of Colorectal Neoplasms a Single Center Prospective Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Colorectal cancer CRC is the third most common malignancy and the second leading cause of cancer-related death worldwide Colonoscopy is considered the preferred method of screening for colorectal cancer and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer In order to improve the qualitative and quantitative diagnosis of colorectal lesions many endoscopic techniques such as image-enhanced endoscopy IEE including narrowband imaging NBI magnifying endoscopy pigment endoscopy confocal laser endoscopy and endocytoscopy EC are applied clinically However with the increasing number of endoscopic resection the costs associated with the pathological diagnosis of endoscopic resection and resection specimens increase year by year In clinical practice some non-neoplastic colorectal lesions may not require resection so it is important to distinguish neoplastic from non-neoplastic during colonoscopy The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC Based on the endoscopic diagnosis the endoscopist can determine the treatment plan for the colorectal lesions The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x EC can demonstrate the atypical of gland structure and cells after staining and display the super-amplified surface microvessels of the lesion under the EC-NBI mode However the judgment of endocytoscopic images needs a lot of experience to improve the diagnostic accuracy Moreover endoscopists have certain subjective judgments and errors in endocytoscopic diagnosis There is an artificial intelligence system which has been developed to identify colorectal neoplasms However there is still a lack of prospective clinical verification based on Chinese population In the study the investigators performed a prospective clinical study to determine the diagnostic accuracy of artificial intelligence system
Detailed Description:
None
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