NCT03009383

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

December 26, 2016

Last Update Submit

July 19, 2018

Conditions

Esophageal Foreign Body

Outcome Measures

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

    Within 1 hr after procedure

Study Arms (1)

A bedside portable endoscopy

EXPERIMENTAL
Device: A bedside portable endoscopy

Interventions

A bedside portable endoscopyDEVICE
A bedside portable endoscopy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 25009396RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 26, 2016

First Posted

January 4, 2017

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

July 23, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)