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Recruiting NCT03961945

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

Trial Parameters

Condition Barrett Esophagus
Sponsor Mayo Clinic
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,550
Sex ALL
Min Age 18 Years
Max Age 90 Years
Start Date 2021-07-01
Completion 2030-07-30
Interventions
Sponge Capsule

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.

Eligibility Criteria

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

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