Status unknownNCT04083573Updated Sep 10, 2019

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

An observational study in Early Gastric Cancer, sponsored by National Cancer Center, Korea. Status unknown. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-09-10.

Sponsored by National Cancer Center, Korea · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Not yet recruiting — may be out of date.

Study type: Observational
Model: Case-only
Time perspective: Cross-sectional
Enrollment: 25
Ages: 19 Years and older
Sex: All

Study 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 studied

Early Gastric Cancer

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In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 25 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

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Lead sponsor

National Cancer Center, Korea is the lead sponsor of 193 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

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

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

Observational model: Case-only
Time perspective: Cross-sectional
Enrollment: 25 participants (estimated)
Patient registry: No

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: 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.

Study locations

No study locations are listed for this record.

References and documents

Publications

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. PubMed 29708640 ↗
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. PubMed 25063416 ↗
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. PubMed 26200516 ↗
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. PubMed 21316050 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04083573
Lead sponsor: National Cancer Center, Korea
Responsible party: Chan Gyoo Kim (Senior Scientist, National Cancer Center, Korea) — Principal investigator
First posted: Sep 10, 2019
Start date: Sep 2019 (estimated)
Primary completion: Dec 2019 (estimated)
Completion: Sep 2020 (estimated)
Last update: Sep 10, 2019

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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