Spots Global Cancer Trial Database for A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus

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Trial Identification

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

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

Study ID: NCT02560623

Conditions

Barrett Esophagus

Interventions

Biopsy

Biospecimen Collection

Endoscopic Procedure

Swallowable Sponge Cell Sampling Device

Study Description

Brief 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.

Detailed 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.