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a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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. Sensitivity and specificity are co-primary endpoints. Samples are collected using the EndoSign Cell collection device, tested in a CLIA lab and compared to endoscopy/pathology diagnosis confirmed by independent central pathology review.
Assess subject self-reported 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
Proportion of Subjects meeting Sample Assay Requirements
Proportion of subjects among those with cell samples obtained and sent to the central laboratory for processing with DNA yield as well as QC pass of the sequencing process by applying thresholds specified in the laboratory's CLIA/CAP documentation.
Performance of BE Test by Prague, Histopathology grade and Seattle Protocol Adherence.
Sensitivity by histopathological grade: NDBE, all BE with neoplasia or EAC, and separately for indefinite for dysplasia (IND), low grade dysplasia (LGD), high grade dysplasia (HGD) / intramucosal carcinoma (IMC), and EAC. Sensitivity by length of BE segment. Short-segment BE is defined as \<3 cm in length . Long-segment BE is defined as 3 cm or longer. Sensitivity and specificity of the Barrett's Esophagus Test in the subgroup entering via the HRS pathway. Sensitivity and Specificity based on adherence to the Seattle biopsy Protocol Lack of adherence to the Seattle biopsy protocol (defined as either: 1) \<1 specimen jar per 2 cm of BE and/or 2) lack of documentation of adhering to the biopsy protocol) is common and may impact detection of true positive BE patients. Sensitivity and specificity will be dichotomized by Seattle protocol status, and false positive cases will be compared to true positives for adherence to the protocol.
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.
Characterize the safety profile of the EndoSign Cell Collection Device as used in this study by noting the frequency and severity of adverse events or adverse device effects related to the device administration.
Characterize the safety profile of the EndoSign Cell Collection Device as used in this study by noting the frequency and severity of adverse events or adverse device effects related to the device administration. Assessed by subject self-report per discharge instructions, urgent care or ER visit, call to treating or research physician.
Positive and Negative Predictive values as an additional, but not primary endpoint.
Positive Predictive Value (the proportion of subjects who have Barrett's Esophagus among subjects with positive test results, PPV) and Negative Predictive Value (the proportion of subjects who do not have Barrett's Esophagus among subjects with negative test results, NPV) among the subset of patients entering the study via the high-risk screening pathway will be computed to complement the information provided by sensitivity and specificity.
Demographic and other Descriptive Summaries
Categorical variables (such as race, ethnicity, or whether a patient has BE) generally will be summarized using frequencies and proportions or percentages, while continuous variables (such as age or BE segment length) generally will be summarized using means, standard deviations (SDs), and/or medians and quartiles or ranges. When summarizing continuous variables, no confirmed values, outside allowable ranges or otherwise, will be considered outliers. Missing values generally will be reported as such in descriptive summaries.
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