This study is looking at cells collected from the esophagus using a diagnostic device called the EndoSign® Cell Collection Device (a sponge on a thread). Subjects swallow a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread. These cells will be tested to check for a condition called "Barrett's Esophagus."
The cells from the sponge will be tested using Cyted Health biomarkers and compared to the results from a regular endoscopy and any biopsies that are taken. To do this, we need sponge samples from people who might have Barrett's Esophagus based on their risk factors, and from people with Barrett's Esophagus.
Subjects will have one visit to have the Endosign Cell Collection Device administered prior to having a standard of care endoscopy. They will answer some questions about their medical history and experience with the cell collection procedure as part of the study. Data will be collected from medical records including post-endoscopy.
Willing to undergo non-endoscopic sampling with the study device prior to EGD (up to 6 weeks prior to EGD/EET or day of EGD/EET).
Willing and able to sign informed consent
Confirmed Barrett's Esophagus of length at least 1 cm or greater. This includes non-dysplastic Barrett's, low-grade dysplasia, high-grade dysplasia or adenocarcinoma.
Previous EGD result was indefinite for dysplasia
Previous endoscopic eradication therapy (EET)
Current dysphagia (unable to swallow a pill the size of the capsule (8.5 mm dia.))
Known or suspected gastric or esophageal varices
Subjects scheduled for EGD (upper endoscopy) that meet the eligibility criteria at recruiting centers.
Case-control
Prospective
Barrett's Esophagus Test (LDT)
DeviceBarrett's Esophagus Test (LDT) will be performed on esophageal cells collected using the EndoSign Cell Collection Device (510(k) cleared) and compared to the results of standard of care EGD plus biopsies (if applicable)
Performance of Barrett's Esophagus Test (LDT) compared to standard of care.
Performance of the biomarker for detecting BE or confirming no BE in the study population including sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) on samples collected using the EndoSign Cell collection device as compared to endoscopy and pathology.
Assess subject experience with the EndoSign Cell Collection Device
Use of a 10-point scale to assess subject's experience with the device where 0 is no issues and 10 is the worst experience on a number of device-specific questions
Interim assessment of number of subjects with each diagnosis
At 50% total recruitment to various diagnoses, the Sponsor will evaluate the number of subjects in that cohort with complete clinical data and sample collection. The Sponsor may issue notices to recruiting sites temporarily or permanently closing a cohort to new subjects.
Click on the lead sponsor to view all of their trials.
