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Barrett EsophagusNCT03961945

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

A study testing Sponge Capsule in people with Barrett Esophagus and Esophageal Adenocarcinoma, run by Mayo Clinic at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Barrett Esophagus, Esophageal Adenocarcinoma
What is being tested?
Sponge Capsule
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,526 participants
Where
8 sitesUnited States
Study dates
1 Jul 2021to 25 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.

Who cannot join

  • 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
Show all 27Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Mayo Clinic Health Systems - Austin

    Austin, Minnesota, 55912

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75246

  • Mayo Clinic Health System-Eau Claire

    Eau Claire, Wisconsin, 54701

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • Mayo Clinic Health Systems - Mankato

    Mankato, Minnesota, 56001

  • Northwell Health

    New Hyde Park, New York, 11040

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

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.

Read the detailed description

The sponge on a string (SOS) device will be safely administered by a non-physician such as a nurse. Novel discriminant methylated DNA markers will be assayed on esophageal cytology specimens obtained from the SOS device to enable detection in Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection.

Being tested
Sponge Capsule
Keywords
Barrett's Esophagus, Gastroesophageal Reflux, Reflux, Esophageal Cancer, Esophageal Adenocarcinoma
Medical subject headings
Barrett Esophagus, Adenocarcinoma Of Esophagus, Gastroesophageal Reflux, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sponge CapsuleDevice

    Also called EsophaCap, Cytosponge

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

Study groups in NCT03961945
Study groupRoleWhat they receive
Screening PopulationOtherThose 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.
Receives: Device: Sponge Capsule
Upper endoscopy - Barrett's EsophagusOtherThose 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.
Receives: Device: Sponge Capsule
Upper endoscopy - No Barrett's EsophagusOtherThose 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.
Receives: Device: Sponge Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aim 1 - Screening Population

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

    Measured: 5 years

  2. Aim 2 - Case/Control Population BE Detection

    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.

    Measured: 5 years

  3. Aim 3 - Dysplasia Detection Sensitivity and Specificity

    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.

    Measured: 5 years

Secondary outcomes (4)

  1. Aim 1 - Screening Population Predictive Value

    Compare positive predictive value and negative predictive value of the sponge capsule Barrett's Esophagus test between those with and without chronic GERD.

    Measured: 5 years

  2. Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure

    Safety and tolerability of the sponge capsule device in a screening population as measured by a Tolerability Questionnaire with sponge capsule procedure. Participants will rate their tolerability by rating questions using a scale of 0-10 (0 is none and 10 is severe or 0 is good and 10 is not good).

    Measured: 5 years

  3. Aim 2 - Case/Control Population Sensitivity and Specificity

    Validate specificity and sensitivity cut offs of a BE prediction algorithm in an independent patient cohort

    Measured: 5 years

  4. Aim 3 - Dysplasia Detection Rate of Missed Dysplasia

    Measure diagnostic uncertainty bias in the criterion standard, specifically, the rate of dysplasia missed by surveillance histology

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2019
  2. Study start1 Jul 2021
  3. Primary completion25 Nov 2025
  4. Study completion25 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03961945
Sponsor's protocol ID
19-002629
Other IDs
R01CA241164, NCI-2021-14395
Status last verified
Oct 2026
First submitted
15 May 2019
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sponge Capsule in people with Barrett Esophagus and Esophageal Adenocarcinoma, run by Mayo Clinic at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aim 1 - Screening Population (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03961945.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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