Recruiting

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

Sponsor:

Mayo Clinic

Code:

NCT03961945

Conditions

Barrett Esophagus

Esophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Sponge Capsule

Study Details

Brief summary:

This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.

Conditions

Barrett Esophagus

Esophageal Adenocarcinoma

Study ID

NCT03961945

Start date

Jul 1, 2021

Status verified date

Jan, 2026

Completion date

Jul 30, 2030

Anticipated

Primary completion date

Jul 30, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1550 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Screening Population

Those that have gastroesophageal reflux or other risk factors for Barrett's Esophagus will be contacted and if agreeable undergo sponge capsule procedure and fill out questionnaires.

other: Upper endoscopy - Barrett's Esophagus

Those that have a diagnosis of Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.

other: Upper endoscopy - No Barrett's Esophagus

Those that have no known Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.

Interventions

Sponge Capsule

Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.

Primary outcome measure

Aim 1 - Screening Population [ Time Frame: 5 years ]
Aim 2 - Case/Control Population BE Detection [ Time Frame: 5 years ]
Aim 3 - Dysplasia Detection Sensitivity and Specificity [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic Health Systems - Austin

Recruiting

Austin, Minnesota, United States, 55912

Contacts

Ramona Lansing, RN

507-538-4974 lansing.ramona@mayo.edu

Principal Investigator:

Eduardo Antpack, MD

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Ramona Lansing, R.N.

507-538-4974 lansing.ramona@mayo.edu

Principal Investigator:

Prasad G. Iyer, M.D.

Mayo Clinic Health System-Eau Claire

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Rebecca L. Schmidt, R.N.

715-838-5137 Schmidt.Rebecca2@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

Barrett's Esophagus
Gastroesophageal Reflux
Reflux
Esophageal Cancer
Esophageal Adenocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-26.