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CompletedNCT03009383Updated Jul 23, 2018

A Bedside Portable Endoscopy for the Esophageal Foreign Body

An interventional study of A bedside portable endoscopy in Esophageal Foreign Body, sponsored by Kyungpook National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-07-23.

Sponsored by Kyungpook National University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether a bedside portable endoscopy is effective in identifying the esophageal foreign body in the emergency room.

02

Conditions studied

  • Esophageal Foreign Body

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03

In context

Foreign Bodies

29 studies on the registry are indexed under Foreign Bodies; 8 are open to participants now.

Browse Foreign Bodies studies →

Lead sponsor

Kyungpook National University Hospital is the lead sponsor of 80 studies on the registry; 8 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who visit the emergency room due to apparent foreign body in esophagus

Exclusion criteria

Exclusion Criteria:

  • Patients unable to insert a portable endoscopy through the nasal cavity
  • Patients unable to undergo conventional esophagogastroduodenoscopy for a gold standard examination
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    A bedside portable endoscopy

    Device: A bedside portable endoscopy

Interventions

  • DeviceA bedside portable endoscopy
06

What researchers measure

Primary outcomes

  1. Sensitivity, specificity, positive predictive value and negative predictive value of the bedside portable endoscopy to identify esophageal foreign body defined by comparison with conventional esophagogastroduodenoscopy as a gold standard method

    Time frame: Within 1 hr after procedure

07

Study locations

1 site
  • Kyungpook National University Hospital
    Daegu, 41944, Korea, Republic of
08

References and documents

Publications

  • Choi JH, Choi JH, Lee YJ, Lee HK, Choi WY, Kim ES, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Comparison of a novel bedside portable endoscopy device with nasogastric aspiration for identifying upper gastrointestinal bleeding. World J Gastroenterol. 2014 Jul 7;20(25):8221-8. doi: 10.3748/wjg.v20.i25.8221. PubMed 25009396 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2016, a primary completion of Oct 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 26, 2016
First posted
Jan 4, 2017
Start
Oct 2016
Primary completionActual
Oct 2017
CompletionActual
Dec 2017
Last update
Jul 23, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03009383
Lead sponsor
Kyungpook National University Hospital
Responsible party
Eun Soo Kim, MD, PhD (Associate professor, Kyungpook National University Hospital) — Principal investigator
First posted
Jan 4, 2017
Start date
Oct 2016
Primary completion
Oct 2017
Completion
Dec 2017
Last update
Jul 23, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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