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

NCT04083573 | Unknown

• 1 other identifier: NCC2019-0153
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Early Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Consistency between the result from medical monitor and that from medical augmented reality glass

  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.

  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.

Interventions

application of medical augmented reality glasses OTHER

Endoscopic images from medical monitor and medical augmented reality glasses will be collected and reviewed. Outcomes from both series of images will be compared

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with early gastric cancer who are scheduled for endoscopic submucosal dissection will be the study population

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Related Publications (4)

• Yoon JW, Chen RE, Kim EJ, Akinduro OO, Kerezoudis P, Han PK, Si P, Freeman WD, Diaz RJ, Komotar RJ, Pirris SM, Brown BL, Bydon M, Wang MY, Wharen RE Jr, Quinones-Hinojosa A. Augmented reality for the surgeon: Systematic review. Int J Med Robot. 2018 Aug;14(4):e1914. doi: 10.1002/rcs.1914. Epub 2018 Apr 30.

  PMID: 29708640 BACKGROUND

• Takeshita H, Kihara K, Yoshida S, Higuchi S, Ito M, Nakanishi Y, Kijima T, Ishioka J, Matsuoka Y, Numao N, Saito K, Fujii Y. Clinical application of a modern high-definition head-mounted display in sonography. J Ultrasound Med. 2014 Aug;33(8):1499-504. doi: 10.7863/ultra.33.8.1499.

  PMID: 25063416 BACKGROUND

• Eckardt C, Paulo EB. HEADS-UP SURGERY FOR VITREORETINAL PROCEDURES: An Experimental and Clinical Study. Retina. 2016 Jan;36(1):137-47. doi: 10.1097/IAE.0000000000000689.

  PMID: 26200516 BACKGROUND

• Choi J, Kim SG, Im JP, Kim JS, Jung HC, Song IS. Endoscopic prediction of tumor invasion depth in early gastric cancer. Gastrointest Endosc. 2011 May;73(5):917-27. doi: 10.1016/j.gie.2010.11.053. Epub 2011 Feb 11.

  PMID: 21316050 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: September 10, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: September 1, 2020
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share