Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples

Официальное название

Non-Endoscopic Detection of Barrett's Esophagus and Esophageal Neoplasia Using Methylation Biomarkers on Endosign® Cell Collection Device Samples

Обзор

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a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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.

Вмешательства

• Устройство Barrett's Esophagus Test (LDT)
  Barrett'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)

Первичные конечные точки

• Performance of Barrett's Esophagus Test (LDT) compared to standard of care. [Срок оценки: Sample collection prior to standard of care endoscopy]

Вторичные конечные точки (3)

• Assess subject self-reported experience with the EndoSign Cell Collection Device [Срок оценки: At the Baseline Visit]
• Proportion of Subjects meeting Sample Assay Requirements [Срок оценки: At study completion, about 1.5 years]
• Performance of BE Test by Prague, Histopathology grade and Seattle Protocol Adherence. [Срок оценки: Sample collection prior to standard of care endoscopy]

Критерии участия

High Risk Screening: Closed November 2025 Barrett's Esophagus Inclusion Criteria

• Undergoing a standard of care EGD (with or without endoscopic eradication therapy {EET})
• 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.

Критерии исключения

• 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
• Known or suspected portal hypertension
• Taking anti-thrombotic medications that cannot be discontinued
• Taking GLP-1 agonists that cannot be discontinued for 1 week prior to sponge administration
• Previous gastric or esophageal surgery (including Nissen fundoplication)
• History of oropharyngeal tumor
• History of myocardial infarction or cerebrovascular accident in past 6 months
• Known or suspected to be pregnant (self-report for woman of child-bearing potential)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• Gastroenterology Practice — Cordova

Идентификаторы

NCT: NCT06803927 · ENDOEXT-28

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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