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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
242
Undergo biopsy
Undergo collection of blood sample
Undergo endoscopy
Mayo Clinic
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic Health System - Mankato
Mankato, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Number of Subjects That Would Have This Procedure Again
Number of subjects that answered yes to the self-reported question "Would you choose to have this procedure again to screen for Barrett's esophagus?"
Time frame: Within 24 hours of the capsule sponge administration
Tolerability of Swallowing the Sponge Device
Measured using a self-reported 5-item tolerability assessment rating discomfort during the procedure on a Likert scale of 0-10; 10 representing the "worst experience" and 0 the "best experience." This scale allows a comprehensive and individual assessment of the degree of pain, choking, gagging, anxiety and overall experienced during the procedure.
Time frame: Within 24 hours of the capsule sponge administration
Mucosal Irritation
Measured using a mucosal injury score (ranging from 1=no trauma to 5=severe) was scored from video recordings of the subsequent endoscopy conducted
Time frame: Within 24 hours of the capsule sponge administration
DNA Yield
Total amount of DNA obtained from esophageal cytology specimens collected by the capsule sponge devices.
Time frame: Within 24 hours of the capsule sponge administration
Sensitivity of Barrett's Dysplasia Detection
The sensitivity methylated DNA markers detected by the capsule sponge, in making a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard.
Time frame: Within 24 hours of the capsule sponge administration
Specificity of Barrett's Dysplasia Detection
The specificity of methylated DNA markers detected by the capsule sponge, in identifying subjects without a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard.
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Undergo swallowable sponge cell sampling assessment
Northwell Health
Manhasset, New York, United States
Baylor University Medical Center
Dallas, Texas, United States
Time frame: Within 24 hours of the capsule sponge administration