Comparison of Diagnostic Performance of Medical Monitor and Medical Augmented Reality Glasses in Endoscopy: Observation Study

• Conditions: Early Gastric Cancer

• Registration Number: NCT04083573
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

The purpose of this study was to compare the outcomes of medical augmented reality glasses and general monitors when distinguishing mucosal lesions from submucosal lesions in endoscopic diagnosis for early gastric cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-26
• Status Verified: 2019-09
• Study Start: 2019-09
• Study First Submitted QC: 2019-09-05
• Last Update Submitted: 2019-09-05
• Study First Posted: 2019-09-10
• Last Update Posted: 2019-09-10
• Primary Completion: 2019-12
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients with early gastric cancer who are scheduled for endoscopic submucosal dissection
• Age 19 or more
• Patients who voluntarily participated in this clinical study and signed a written informed consent

Exclusion Criteria

• Patients with poor general medical condition which does not allow them to understand and submit a informed consent
• Patients who do not agree with this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Consistency between the result from medical monitor and that from medical augmented reality glass	Image review will be conducted after full collection of both series of images. Review process will be done within 3 months after acquision of images. The time for study completion is aimed at 1 year from the start date.	All series of images will be reviewed by several endoscopists by evaluation of several endoscopic findings.; Then, concordance rate between the result from medical monitor and that from medical augmented reality glass will be assessed.; More specifically, % of patients that does not show the same results (m cancer, sm cancer, or indeterminate) between medical monitor and medical augmented reality will be assessed.