NCT03961945

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,550 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Barrett Esophagus
• Esophageal Adenocarcinoma

Interventions

Type	Name	Description
DEVICE	Sponge Capsule	Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.

Timeline

• Start date: 2021-07-01
• Primary completion: 2030-07-30
• Completion: 2030-07-30
• First posted: 2019-05-23
• Last updated: 2026-01-26

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study