MedTrace Logo

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

NCT03961945 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1550

Last updated 2026-01-26

No results posted yet for this study

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

Interventions

DEVICE

Sponge Capsule

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Prasad G. Iyer, M.D. · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2030-07-30
Completion
2030-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03961945 on ClinicalTrials.gov