Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317103
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2024-03-05
Brief Title:
A Clinical Trial to Evaluate the Sensitivity and Specificity of WAYMED Endo Compared to the Endoscopists in Classifying Early Gastric Cancer EGC Based on the Depth of Invasion in Endoscopic Images
Sponsor:
WAYCEN Inc
Organization:
WAYCEN Inc
Study Overview
Official Title:
A Retrospective Single Center Double Arm Blind Controlled Pivotal Trial to Evaluate Classification by the Depth of Invasion of Early Gastric Cancer Sensitivity and Specificity of Gastric Cancer Image Computer Aided Detection and Diagnosis Software WAYMED Endo and Endoscopists in Endoscopic Images
Status:
COMPLETED
Status Verified Date:
2024-03
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:
The purpose of this clinical trial is to prove that the prediction capability of WAYMED endo is superior to that of the endoscopists in classifying EGC based on the depth of invasion categories in gastro-endoscopic images
The computer-aided detectiondiagnosis software is an Artificial Intelligence AI software used to assist medical specialists in diagnostic decisions by automatically classifying EGC based on the depth of invasion categories in gastro-endoscopic images and displaying the results and possibilities on the User Interface UI
The computer-aided detectiondiagnosis software is an Artificial Intelligence AI software used to assist medical specialists in diagnostic decisions by automatically classifying EGC based on the depth of invasion categories in gastro-endoscopic images and displaying the results and possibilities on the User Interface UI
Detailed Description:
This clinical trial aims to evaluate the sensitivity and specificity of WAYMED endo compared to that of endoscopists in classifying EGC based on the depth of invasion categories in gastro-endoscopic images It is designed as a retrospective single-center double-arm double-blind endoscopist investigational medical device applicator controlled and pivotal trial Medical data collected retrospectively from subjects who underwent Esophagogastroduodenoscopy EGD and biopsy are screened As a result of screening medical data that meet all inclusionexclusion criteria are enrolled and assigned to the trial and control groups
In the trial group the investigational medical device is applied to the images while the endoscopists interpret the images in the control group The Reference Standard Establishment Committee records the reference standard results as either Mucosa mucosal invasion or Submucosa submucosal invasion based on the depth of invasion of the lesion and marks the detected lesion area with an oval on the image The reference standard results are blinded so they cannot be disclosed to the endoscopists or the investigational medical device applicator
The primary endpoint includes the sensitivity and specificity of WAYMED endo and the endoscopists in classifying EGC based on the depth of invasion categories Mucosa or Submucosa as confirmed by the reference standard The secondary endpoint includes the accuracy of WAYMED endo and the endoscopists in accurately classifying all early gastric cancer images as either Mucosa or Submucosa based on the depth of invasion categories as confirmed through pathological examination
In the trial group the investigational medical device is applied to the images while the endoscopists interpret the images in the control group The Reference Standard Establishment Committee records the reference standard results as either Mucosa mucosal invasion or Submucosa submucosal invasion based on the depth of invasion of the lesion and marks the detected lesion area with an oval on the image The reference standard results are blinded so they cannot be disclosed to the endoscopists or the investigational medical device applicator
The primary endpoint includes the sensitivity and specificity of WAYMED endo and the endoscopists in classifying EGC based on the depth of invasion categories Mucosa or Submucosa as confirmed by the reference standard The secondary endpoint includes the accuracy of WAYMED endo and the endoscopists in accurately classifying all early gastric cancer images as either Mucosa or Submucosa based on the depth of invasion categories as confirmed through pathological examination
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