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Pill-Sized device could replace endoscopy for esophageal cancer risk

NCT ID NCT03830801

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests a new swallowable capsule that uses optical coherence tomography (OCT) to take detailed images of the esophagus and collect targeted tissue samples from areas of concern in people with Barrett's esophagus. The goal is to see if this less invasive method can provide enough tissue for genomic analysis to better predict the risk of developing esophageal cancer. The study involves 30 participants and focuses on the feasibility of the technique.

What this could mean

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

Active substance
IVLCM tethered capsule (device)
What this could lead to
If successful, this could lead to a less invasive way to collect tissue samples from Barrett's esophagus, potentially improving early detection of esophageal cancer risk without the need for traditional endoscopy.
What could go wrong
This is a very early pilot study with only 30 participants, so it is not yet proven to work in practice. The technology may not reliably collect enough tissue for analysis, and results may not apply to all patients.

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 30 people

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

Started

Dec 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 must have a current or prior diagnosis of Barrett's Esophagus * Participants must be over the age of 18. * Participants must be able to give informed consent. Exclusion Criteria: * Pregnant women. * Participants who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure. * Participants with a history of hemostasis disorders. * Participants with esophageal strictures, resulting in a luminal diameter smaller than the diameter of the capsule. * Participants with a know history of esophageal varices * Participants above 80 years of age

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

    Contact Email: •••••@•••••

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