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

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.

Conditions studied

Esophageal Foreign Body

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Foreign Bodies 44

Who can participate

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

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

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

What researchers measure

Primary outcomes

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

Study locations

1 site

Kyungpook National University Hospital
Daegu, 41944, Korea, Republic of

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

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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