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Sponge Capsule for Barrett's Esophagus and Esophageal Cancer Detection

This study is testing a new device called a "Sponge Capsule" to see if it can accurately find Barrett's Esophagus and early signs of esophageal cancer (dysplasia/adenocarcinoma). You would swallow this capsule, and it collects cells from your esophagus. The study aims to see how well this device works in people who may be at risk for Barrett's Esophagus, including those with chronic acid reflux (gastroesophageal reflux disease). Researchers will measure the device's accuracy over five years. The study is looking for 1550 participants, aged 18 to 90, who have at least three risk factors for Barrett's Esophagus, or a diagnosis of GERD, or have used certain acid reflux medications for at least three months in the last five years. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 1550 participants. It is not specified if it is randomized or blinded.
What's involved
You would swallow a sponge capsule, which will collect cells from your esophagus. This procedure will be done by a non-physician, such as a nurse.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes related to the device's accuracy over a period of 5 years.

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NCT03961945

Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma

Recruiting
NAAges 18–90InterventionalDiagnostic
Mayo Clinic
~1,550 participants
Updated 2026-01-26 on ClinicalTrials.gov
What's tested:Sponge Capsule

At a glance

Recruiting sites
3 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Aim 1 - Screening Population
Measured over 5 years
+2 more outcomes measured

Conditions

Barrett Esophagus
Esophageal Adenocarcinoma

Explore related trials

Barrett EsophagusEsophageal AdenocarcinomaGastroesophageal Reflux

Where it's being run

9 sites across 6 states
Minnesota3
Wisconsin2
Arizona1
Florida1
New York1
Texas1

Study leadership

  • Prasad G. Iyer, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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
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.

What this trial measures

  • Aim 1 - Screening Population5 years

    To measure the positive and negative predictive value of the sponge capsule Barrett's esophagus test in a screening population.

  • Aim 2 - Case/Control Population BE Detection5 years

    Compare the sensitivity and specificity of a predetermined BE prediction algorithm for those with and without GERD and assess the influence of other covariates (age, sex, ever smoking, ethnicity and BMI) on this algorithm.

  • Aim 3 - Dysplasia Detection Sensitivity and Specificity5 years

    Measure the sensitivity and specificity of a predetermined MDM panel assayed on SOS specimens from BE patients identified in Aims 1 and 2, for the detection of HGD /EAC, using surveillance histology as the criterion standard.