NCT02560623

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Barrett Esophagus

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo collection of blood sample
PROCEDURE	Endoscopic Procedure	Undergo endoscopy
DEVICE	Swallowable Sponge Cell Sampling Device	Undergo swallowable sponge cell sampling assessment

Timeline

• Start date: 2015-10-15
• Primary completion: 2021-06-29
• Completion: 2021-07-08
• First posted: 2015-09-25
• Last updated: 2022-11-17
• Results posted: 2022-09-16

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study