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Swallow a sponge, skip the scope: new test could spot esophagus condition

NCT ID NCT06803927

Diagnosis Sponsor: Cyted Health Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study tests a simple, non-invasive device called EndoSign, which is a sponge on a string that you swallow in a capsule. The sponge collects cells from the esophagus, which are then tested for signs of Barrett's esophagus, a condition that can lead to cancer. The results will be compared to standard endoscopy and biopsies. The trial involves 700 participants who either have Barrett's esophagus or are at high risk for it.

What this could mean

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

Active substance
EndoSign Cell Collection Device (sponge on a string) with methylation biomarker test
What this could lead to
If successful, this could offer a simple, non-invasive way to screen for Barrett's esophagus, potentially catching it early and reducing the need for regular endoscopies.
What could go wrong
This is a diagnostic study, not a treatment. The test may not be as accurate as endoscopy, and results need further validation before widespread use.

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.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Subjects scheduled for EGD (upper endoscopy) that meet the eligibility criteria at recruiting centers.

Ages

18 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.

High Risk Screening: Closed November 2025 Barrett's Esophagus Inclusion Criteria * Undergoing a standard of care EGD (with or without endoscopic eradication therapy {EET}) * Willing to undergo non-endoscopic sampling with the study device prior to EGD (up to 6 weeks prior to EGD/EET or day of EGD/EET). * Willing and able to sign informed consent * Confirmed Barrett's Esophagus of length at least 1 cm or greater. This includes non-dysplastic Barrett's, low-grade dysplasia, high-grade dysplasia or adenocarcinoma. Exclusion Criteria * Previous EGD result was indefinite for dysplasia * Previous endoscopic eradication therapy (EET) * Current dysphagia (unable to swallow a pill the size of the capsule (8.5 mm dia.)) * Known or suspected gastric or esophageal varices * Known or suspected portal hypertension * Taking anti-thrombotic medications that cannot be discontinued * Taking GLP-1 agonists that cannot be discontinued for 1 week prior to sponge administration * Previous gastric or esophageal surgery (including Nissen fundoplication) * History of oropharyngeal tumor * History of myocardial infarction or cerebrovascular accident in past 6 months * Known or suspected to be pregnant (self-report for woman of child-bearing potential)

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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 esophagus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Gastroenterology Practice

    RECRUITING

    Cordova, Tennessee, 38138, United States

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