NCT03961945 · Mayo Clinic
Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and female ages 50-85
- Patients who have three or more risk factors for Barrett's Esophagus.
- Gastroesophageal reflux disease defined by:
- 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.
Where
- Scottsdale, Arizona
- Jacksonville, Florida
- Austin, Minnesota
- Mankato, Minnesota
- Rochester, Minnesota
- New Hyde Park, New York
- Dallas, Texas
- Eau Claire, Wisconsin
- La Crosse, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 26, 2026 · Source of record for eligibility and locations