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Swallow a sponge to detect esophageal cancer? new study investigates

NCT ID NCT03961945

What the study statuses mean

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study is testing a new, less invasive way to diagnose Barrett's esophagus and esophageal cancer using a sponge capsule that patients swallow. The sponge collects cells from the esophagus, which are then analyzed for signs of disease. Researchers will enroll 1,550 people aged 50-85 with risk factors like chronic acid reflux to see how accurate the sponge test is compared to standard endoscopy.

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 1,550 people

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

Started

Jul 2021

Expected to finish

Jul 2030

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 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 Aim1: * Male and female ages 50-85 * Patients who have three or more risk factors for Barrett's Esophagus. * Gastroesophageal reflux disease defined by: * Diagnosis * Use of one of the following drugs \>= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine * prior endoscopic diagnosis of erosive esophagitis * Body mass index (BMI) \>= 30 Exclusion Criteria Aim1 and Aim 3: * Previous history of: * esophageal adenocarcinoma/cancer * esophageal squamous carcinoma * endoscopic ablation for Barrett's esophagus * esophageal squamous dysplasia * Current treatment with oral anticoagulation including Warfarin, Coumadin * History of cirrhosis * History of esophageal/gastric varices * History of Barrett's esophagus * Prior endoscopy in the last 5 years Inclusion criteria Aim 2 and Aim 3: * Subjects with known or suspected BE (cases). * Patient between the ages 18 - 90. * Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record. * Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record. * Undergoing clinically indicated endoscopy. * Subjects without known history of BE (controls). * Undergoing clinically indicated diagnostic endoscopy. Exclusion criteria Aim 2: * Subjects with known BE. * Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) alone will not be excluded. * Patients with history of esophageal resection for esophageal carcinoma. * For subjects with or without known evidence of BE (on history or review of medical records): * Pregnant or lactating females. * Patients who are unable to consent. * Patients with current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study). * History of eosinophilic esophagitis, achalasia. * Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study). * Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure. * Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure. * Patients with history of known esophageal or gastric varices or cirrhosis. * Patients with history of surgical esophageal resection for esophageal carcinoma. * Patients with congenital or acquired bleeding diatheses. * Patients with a history of esophageal squamous dysplasia. * Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment. * Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

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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.

  1. The study's own enquiry address

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

  2. The places running it

    3 sites. 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: •••••@•••••

Locations

  • Baylor Scott & White Research Institute

    COMPLETED

    Dallas, Texas, 75246, United States

  • Mayo Clinic Arizona

    COMPLETED

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Health System-Eau Claire

    RECRUITING

    Eau Claire, Wisconsin, 54701, United States

  • Mayo Clinic Health System-Franciscan Healthcare

    WITHDRAWN

    La Crosse, Wisconsin, 54601, United States

  • Mayo Clinic Health Systems - Austin

    RECRUITING

    Austin, Minnesota, 55912, United States

  • Mayo Clinic Health Systems - Mankato

    COMPLETED

    Mankato, Minnesota, 56001, United States

  • Mayo Clinic Jacksonville

    COMPLETED

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

  • Northwell Health

    COMPLETED

    New Hyde Park, New York, 11040, United States

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