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No heartburn? no problem? simple swallow test spots hidden esophagus risk

NCT ID NCT04880044

Diagnosis Sponsor: Case Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new, office-based test called EsoCheck/EsoGuard to detect Barrett's esophagus in 132 people who do not have chronic heartburn but have other risk factors like being over 50, white, male, or having central obesity. Participants swallowed a capsule on a string to collect a sample from the esophagus, which was then tested for DNA markers. Those with a positive result underwent a standard endoscopy to confirm. The goal was to see how well this simpler test could identify Barrett's esophagus without needing a full endoscopic procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EsoCheck/EsoGuard (EC/EG) diagnostic test
What this could lead to
If successful, this could offer a simple, non-endoscopic way to screen for Barrett's esophagus in people without heartburn, potentially catching the condition earlier.
What could go wrong
This is a small, completed study focused on diagnostic accuracy, not a treatment trial. The test may not be widely adopted or may miss some cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

132 people

The number who actually took part.

Started

Jan 2022

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * No known coagulopathy, no known esophageal varices. * No significant dysphagia or odynophagia * Absence of chronic GERD, defined as five or more years of heartburn or regurgitation with symptoms at least once a week when not on medications for GERD symptoms. * Subjects to qualify must meet criterion 3, be over age 50, and have two additional risk factors for BE (white race, central obesity defined as waist size \>35 inches for women and \>40 inches for men, male gender, current smoker or smoking history \>10 pack years, confirmed family history in at least two members with one being a first degree relative). Exclusion Criteria: * History of prior EGD procedure * Inability to provide written informed consent * History of weekly of more frequent heartburn or regurgitation for five or more years * On anti-coagulant drug(s)that cannot be temporarily discontinued or coagulopathy with international normalized ratio (INR) \> 1.5 * Known history of esophageal varices or esophageal stricture * Any contraindication, as deemed inInvestigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGDprocedure,and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration * History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills * Oropharyngeal tumor * History of esophageal or gastric surgery, with exception on uncomplicated surgical fundoplication procedure * History of myocardial infarction or cerebrovascular accident within past 6 months

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Conditions

The condition(s) this trial relates to.

Barrett esophagus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Barrett's esophagus

Contacts and locations

Locations

  • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.