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Early Gastric CancerNCT04083573

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

An observational study of Early Gastric Cancer, run by National Cancer Center, Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Early Gastric Cancer
What is being tested?
application of medical augmented reality glasses
How many people
25 participants
Where
No sites listed yet
Study dates
Sep 2019to Sep 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

Being tested
application of medical augmented reality glasses
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • application of medical augmented reality glassesOther

    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 is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2019
  2. Study startSep 2019 (estimated)
  3. Primary completionDec 2019 (estimated)
  4. Study completionSep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04083573
Sponsor's protocol ID
NCC2019-0153
Status last verified
Sep 2019
First submitted
26 Aug 2019
Last updated
10 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Early Gastric Cancer, run by National Cancer Center, Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Consistency between the result from medical monitor and that from medical augmented reality glass (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04083573, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.

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