Esophageal Foreign BodyNCT06507670
Point of Care Ultrasound for the Detection of Esophageal Food Bolus
An observational study of Esophageal Foreign Body and Esophageal Obstruction, run by WellSpan Health at 1 site in United States.
Trial summary
This will be a prospective, observational, case-control study of adult patients presenting to the WellSpan York Hospital Emergency Department (YHED) with signs and symptoms of esophageal food or foreign body impaction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophageal Foreign Body, Esophageal Obstruction
- What is being tested?
- Point of care ultrasound
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This will be a case-control study of adult patients presenting to the WellSpan York Hospital Emergency Department (YHED) with signs and symptoms of esophageal food or foreign body impaction. We will also enroll an age/sex-matched control group of asymptomatic individuals to establish baseline esophageal measurements.
Who may be able to join
- Age ≥18 years
- Signs and symptoms of esophageal food bolus or foreign body
- Age ≥18 years
- NO signs or symptoms of esophageal food bolus or foreign body
- Age/Sex match to previously enrolled case subject
Who cannot join
- Prior esophageal surgery
- History of head/neck cancer
- Incarcerated individuals
- Individuals unable to provide consent
- Clinical instability or airway compromise
- Eligibility (CONTROLS)
Show all 19Show fewer
- Prior esophageal surgery/dilation/pathology
- History of head/neck cancer
- Incarcerated individuals
- Individuals unable to provide consent
- Clinical instability or airway compromise
- Presentation involving any of the following symptoms:
- Nausea/vomiting
- Diarrhea
- Abdominal pain
- Chest pain
- Shortness of breath
- Dysphagia/odynophagia
- Cough
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
WellSpan Health York Hospital
York, Pennsylvania, 17403
Kristen Oliff, 717-851-5075, koliff@wellspan.org
Brent Becker, MD, 717-851-4819, bbecker2@wellspan.org
About this study
This will be a prospective, observational, case-control study of adult patients presenting to the WellSpan York Hospital Emergency Department (YHED) with signs and symptoms of esophageal food or foreign body impaction. Point of care ultrasound (POCUS) will then be performed by a trained emergency physician to collect ultrasound data, including the presence or absence of direct visualization food bolus/foreign body, as well as secondary markers of dilatation, such as maximal esophageal area. Investigators will also enroll an age/sex-matched control group of asymptomatic individuals to establish baseline esophageal measurements.
Patients will otherwise receive medical treatment per standard of care. Subsequent interventions will also be documented, including glucagon, carbonated beverages, and esophagogastroduodenoscopy (EGD). If patients remain in the ED and improve without need for EGD they will undergo repeat ultrasound. Chart review at 1 month will be performed to establish results of EGD including improvement, recurrence, or presence of pathologic abnormalities. The investigators aim to establish normal and abnormal parameters to aid in the diagnosis of esophageal food impactions to predict need for definitive EGD management.
- Conditions
- Esophageal Foreign Body, Esophageal Obstruction
- Being tested
- Point of care ultrasound
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care ultrasoundDiagnostic test
Point of care medical ultrasound machines will be used to sonographically visualize the esophagus and following sonographic data will be collected:
- Presence/absence of suspected foreign body
- Sonographic esophageal measurements (diameters, area)
- Other relevant secondary sonographic findings
| Study group | Role | What they receive |
|---|---|---|
| Esophageal foreign body/impaction (suspected) | Not described Receives: Diagnostic Test: Point of care ultrasound | |
| Control (No symptoms of esophageal foreign body/impaction) | Not described Receives: Diagnostic Test: Point of care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of esophageal foreign body/food impaction
Presence of absence of esophageal foreign body/food impaction on esophagogastroduodenoscopy
Measured: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)
Secondary outcomes (2)
Number/proportion of subjects experiencing resolution of symptoms with standard medical therapies
Number/proportion of subjects experiencing resolution of symptoms with standard medical therapies, including glucagon and carbonated beverages
Measured: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)
Number/proportion of subjects requiring endoscopic intervention
Number/proportion of subjects needing interventional procedures during esophagogastroduodenoscopy due to esophageal symptoms
Measured: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent Becker, WellSpan Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507670
- Sponsor's protocol ID
- 2207289
- Status last verified
- Jun 2026
- First submitted
- 5 Jul 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Ultrasound for the Detection of Esophageal Food Bolus
- ClinicalTrials.gov ID
- NCT06507670
- Acronym / sponsor ID
- 2207289
- Conditions
- Esophageal Foreign Body, Esophageal Obstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 18 Jul 2024 (actual)
- 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.
This will be a prospective, observational, case-control study of adult patients presenting to the WellSpan York Hospital Emergency Department (YHED) with signs and symptoms of esophageal food or foreign body impaction. Point of care ultrasound (POCUS) will then be performed by a trained emergency physician to collect ultrasound data, including the presence or absence of direct visualization food bolus/foreign body, as well as secondary markers of dilatation, such as maximal esophageal area. Investigators will also enroll an age/sex-matched control group of asymptomatic individuals to establish baseline esophageal measurements.
Patients will otherwise receive medical treatment per standard of care. Subsequent interventions will also be documented, including glucagon, carbonated beverages, and esophagogastroduodenoscopy (EGD). If patients remain in the ED and improve without need for EGD they will undergo repeat ultrasound. Chart review at 1 month will be performed to establish results of EGD including improvement, recurrence, or presence of pathologic abnormalities. The investigators aim to establish normal and abnormal parameters to aid in the diagnosis of esophageal food impactions to predict need for definitive EGD management.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esophageal foreign body/impaction (suspected) | – | Diagnostic Test: Point of care ultrasound |
| Control (No symptoms of esophageal foreign body/impaction) | – | Diagnostic Test: Point of care ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This will be a case-control study of adult patients presenting to the WellSpan York Hospital Emergency Department (YHED) with signs and symptoms of esophageal food or foreign body impaction. We will also enroll an age/sex-matched control group of asymptomatic individuals to establish baseline esophageal measurements.
Key inclusion criteria (5 listed)
Key exclusion criteria (19 listed)
- Eligibility (CONTROLS)
- Nausea/vomiting
- Diarrhea
- Abdominal pain
- Chest pain
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 |
|---|---|---|
| Point of care ultrasoundPoint of care medical ultrasound machines will be used to sonographically visualize the esophagus and following sonographic data will be collected: * Presence/absence of suspected foreign body * Sonographic esophageal measurements (diameters, area) * Other relevant secondary sonographic findings | Diagnostic test | Control (No symptoms of esophageal foreign body/impaction), Esophageal foreign body/impaction (suspected) |
Primary outcome
Presence or absence of esophageal foreign body/food impaction
Time frame: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)
Presence of absence of esophageal foreign body/food impaction on esophagogastroduodenoscopy
2 secondary outcomes
Number/proportion of subjects experiencing resolution of symptoms with standard medical therapies
Time frame: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)
Number/proportion of subjects requiring endoscopic intervention
Time frame: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Esophageal Foreign Body
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Foreign Body and Esophageal Obstruction, run by WellSpan Health at 1 site in United States.
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 5 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen Oliff (717-851-5075, koliff@wellspan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of esophageal foreign body/food impaction (time frame: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.