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A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus

Barrett Esophagus Clinical Trial

Official title:
Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device

Clinical Trial Summary

This study is being done to collect data on the potential use of a sponge on a string device as a non-invasive tool in evaluating patients with Barrett's Esophagus compared to healthy controls.

Clinical Trial Description

This study will be conducted in two phases: Phase 1 and Phase 2. Phase 1 will consist of determining the most optimal sponge on a string design (25 mm sponge 20 pores/inch or 25 mm sponge 10 pores/inch) chosen based on participant acceptance, tolerability, mucosal irritation and DNA yield, using a randomized factorial design pilot trial. Participants will first undergo the sponge on a string test followed by clinical endoscopy. Following completion of Phase 1 trial, the most optimal sponge on a string configuration will be chosen for Phase 2. Phase 2 will be conducted using a single size sponge with the same porosity configuration selected from Phase 1. Study procedures, testing and follow up will be the same as Phase 1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02560623
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase N/A
Start date October 15, 2015
Completion date July 8, 2021
View Details
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