Esophageal Foreign BodyNCT03009383
A Bedside Portable Endoscopy for the Esophageal Foreign Body
A study testing A bedside portable endoscopy in people with Esophageal Foreign Body, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Foreign Body
- What is being tested?
- A bedside portable endoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2016to Dec 2017
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who visit the emergency room due to apparent foreign body in esophagus
Who cannot join
- Patients unable to insert a portable endoscopy through the nasal cavity
- Patients unable to undergo conventional esophagogastroduodenoscopy for a gold standard examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Bedside Portable Endoscopy on Identifying the Esophageal Foreign Body
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
- Esophageal Foreign Body
- Being tested
- A bedside portable endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A bedside portable endoscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| A bedside portable endoscopy | Experimental | Not described Receives: Device: A bedside portable endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 1 hr after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Foreign BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Soo Kim, MD, PhD, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009383
- Sponsor's protocol ID
- KNUH20161227
- Status last verified
- Jul 2018
- First submitted
- 26 Dec 2016
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Bedside Portable Endoscopy on Identifying the Esophageal Foreign Body
- ClinicalTrials.gov ID
- NCT03009383
- Acronym / sponsor ID
- KNUH20161227
- Conditions
- Esophageal Foreign Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A bedside portable endoscopy | Experimental | Device: A bedside portable endoscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who visit the emergency room due to apparent foreign body in esophagus
Key exclusion criteria (2 listed)
- Patients unable to insert a portable endoscopy through the nasal cavity
- Patients unable to undergo conventional esophagogastroduodenoscopy for a gold standard examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A bedside portable endoscopy | Device | A bedside portable endoscopy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Results publication: PubMed 25009396Choi 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.
- Individual participant dataSharing planned: No
Related trials for Esophageal Foreign Body
RecruitingObservational study
Point of Care Ultrasound for the Detection of Esophageal Food Bolus
Esophageal Foreign Body, Esophageal Obstruction
Not yet recruitingObservational study
Pediatric GI Endoscopy at Assiut University
Chronic Diarrhea, Persistent Vomitting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A bedside portable endoscopy in people with Esophageal Foreign Body, run by Kyungpook National University Hospital at 1 site in South 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 1 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: finished, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 NCT03009383, which also lists 1 linked publication.
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 23 Jul 2018.