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Swallow a pill to track esophagus changes: new study tests No-Sedation monitoring

NCT ID NCT03459339

Knowledge-focused Sponsor: Massachusetts General Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 500 adults with Barrett's esophagus for 3 years using a tethered capsule endomicroscopy device—a pill-sized camera that patients swallow. The goal is to track how the condition changes over time without needing sedation or a traditional endoscopy. Researchers hope this approach could make monitoring easier and more comfortable for patients.

What this could mean

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

What this could lead to
If successful, this could lead to a simpler, less invasive way to monitor Barrett's esophagus over time.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to any new therapy or change in care.

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

About 500 people

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

Started

Apr 2017

Expected to finish

Dec 2028

An estimate. End dates often move.

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

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.

Inclusion Criteria: * Participants over the age of 18 * Participants who are capable of giving informed consent * Participants with a diagnosis of BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy * Participants who had or will have a standard of care EGD within 15 months, exceptions to this can be submitted to the coordinating center (MGH) for approval Exclusion Criteria: * Participants with prior endoscopic ablation or resection treatment of BE at enrollment visit * Participants with esophageal fistula and/or esophageal strictures * Participants with the inability to swallow capsules * Concomitant chemotherapy treatment * Self reported pregnancy

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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

Contacts and locations

Locations

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • VA Medical Center

    Kansas City, Missouri, 64128, United States

More trials for these conditions

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