Simple balloon test could catch hidden esophagus cancer risk
NCT ID NCT06687603
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times
Summary
This study aims to see if a new office-based test (EsoCheck balloon and EsoGuard lab test) can accurately detect Barrett's esophagus in people who do not have chronic heartburn. Barrett's esophagus is a condition that can lead to esophageal cancer, but it is often missed in people without typical reflux symptoms. About 800 adults scheduled for a routine colonoscopy will take a questionnaire, swallow the capsule balloon, and then have a standard upper endoscopy to compare results.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 800 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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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
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients undergoing screening colonoscopy are an accessible cohort for BE screening and are also a reasonable representation of the general population. Permission will be obtained from colonoscopy physicians for researchers to contact and recruit patients for this study. Patients without GERD, who are at risk for BE, and who have not had a prior EGD, will be recruited prior to or at the time of scheduled colonoscopy.(9) Those eligible will be: * Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have: * No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have: * No significant dysphagia or odynophagia; but who do have: * Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are: * Adults \> age 50, who also have two or more added risk factors for BE from the set of: central obesity (waist size \> 35 inches for women and \> 40 inches for men), current smoker or smoking history \> 10 pack years, white race, male sex, confirmed history of BE/EAC in at least two family members, with one a first degree relative. While BE is most highly prevalent in white males, a black female over age 50 with obesity and a positive smoking history would also be at increased BE risk and would equally meet eligibility criteria. * Subjects must have the ability to understand and the willingness to sign a written informed consent document. * Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * History of prior EGD procedure in past ten years * 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 INR \> 1.5 * Known history of esophageal varices or esophageal stricture * Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, 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 of uncomplicated surgical fundoplication procedure
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic Taussig Cancer Center
RECRUITINGCleveland, Ohio, 44195, United States
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Johns Hopkins Hospital
RECRUITINGBaltimore, Maryland, 21287, United States
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University Hospitals Cleveland Medical Center
RECRUITINGCleveland, Ohio, 44016, United States
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University of Colorado
RECRUITINGAurora, Colorado, 80045, United States
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University of North Carolina at Chapel Hill
RECRUITINGChapel Hill, North Carolina, 027599, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- What do patients really want when facing oesophageal cancer surgery?
- Can a direct hit to tumors make immunotherapy work better?
- Which acid blocker wins in obese reflux patients?
- Can a new drug boost immunotherapy against Hard-to-Treat stomach cancer?
- Through-the-Mouth surgery vs keyhole surgery: which works better for a rare swallowing disorder?