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NCT03961945Completed

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

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
1526 (actual)
First submitted
15 May 2019
Start date
1 Jul 2021
Primary completion date
25 Nov 2025
Lead sponsor
Mayo Clinic
NCT number
NCT03961945

What you commit to

  • Study type: Interventional
  • Participants enrolled: 1526
  • From 1 Jul 2021 to the primary completion date, 25 Nov 2025
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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.

Other illness

  • History of cirrhosis
  • History of esophageal/gastric varices
  • History of Barrett's esophagus

Who the study is looking for

  • 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.

Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Mayo Clinic Health Systems - Austin
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Baylor Scott & White Research Institute
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Mayo Clinic Health System-Eau Claire
Coordinator of this site? Confirm its status
Eau ClaireUnited StatesUnknown status
Mayo Clinic- Jacksonville
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
Mayo Clinic Health Systems-Mankato
Coordinator of this site? Confirm its status
MankatoUnited StatesUnknown status
Northwell Health
Coordinator of this site? Confirm its status
New Hyde ParkUnited StatesUnknown status
Mayo Clinic - Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Mayo Clinic - Arizona
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.