Recruiting

Observational Study

Sponsor:

WellSpan Health

Code:

NCT06507670

Conditions

Esophageal Foreign Body

Esophageal Obstruction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Point of care ultrasound

Study Details

Brief 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. 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

Study ID

NCT06507670

Start date

Jul 1, 2024

Status verified date

Jun, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Eligibility (CASES)

  • Inclusion criteria:

1. Age ≥18 years
2. Signs and symptoms of esophageal food bolus or foreign body
  • Exclusion criteria:

1. Prior esophageal surgery
2. History of head/neck cancer
3. Incarcerated individuals
4. Individuals unable to provide consent
5. Clinical instability or airway compromise

Eligibility (CONTROLS)

  • Inclusion criteria:

1. Age ≥18 years
2. NO signs or symptoms of esophageal food bolus or foreign body
3. Age/Sex match to previously enrolled case subject
  • Exclusion criteria:

1. Prior esophageal surgery/dilation/pathology
2. History of head/neck cancer
3. Incarcerated individuals
4. Individuals unable to provide consent
5. Clinical instability or airway compromise
6. Presentation involving any of the following symptoms:
  • Nausea/vomiting
  • Diarrhea
  • Abdominal pain
  • Chest pain
  • Shortness of breath
  • Dysphagia/odynophagia
  • Cough

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Esophageal foreign body/impaction (suspected)

Control (No symptoms of esophageal foreign body/impaction)

Interventions

Point of care ultrasound

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

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) ]

Central Contacts and Locations

Central contacts

Locations

WellSpan Health York Hospital

Recruiting

York, Pennsylvania, United States, 17403

Contacts

More Information

Sponsor

WellSpan Health

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by WellSpan Health on 2026-06-03.