Swallow a sponge to detect esophageal cancer? new study investigates
NCT ID NCT03961945
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.
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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 1,550 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Jul 2030
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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18 to 90 years
- 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 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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Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 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
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Baylor Scott & White Research Institute
COMPLETEDDallas, Texas, 75246, United States
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Mayo Clinic Arizona
COMPLETEDScottsdale, Arizona, 85259, United States
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Mayo Clinic Health System-Eau Claire
RECRUITINGEau Claire, Wisconsin, 54701, United States
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Mayo Clinic Health System-Franciscan Healthcare
WITHDRAWNLa Crosse, Wisconsin, 54601, United States
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Mayo Clinic Health Systems - Austin
RECRUITINGAustin, Minnesota, 55912, United States
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Mayo Clinic Health Systems - Mankato
COMPLETEDMankato, Minnesota, 56001, United States
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Mayo Clinic Jacksonville
COMPLETEDJacksonville, Florida, 32224, United States
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Mayo Clinic Rochester
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
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Northwell Health
COMPLETEDNew Hyde Park, New York, 11040, United States
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