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NCT Number: NCT06803927

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

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capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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

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Key information

Conditions

Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastroenterology Practice

Cordova, Tennessee, 38138, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • 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)

Treatment and study plan

Barrett's Esophagus Test (LDT)

Device

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)

Primary outcomes

  1. Performance of Barrett's Esophagus Test (LDT) compared to standard of care.

    Time frame: Sample collection prior to standard of care endoscopy

    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.

Secondary outcomes

  1. Assess subject experience with the EndoSign Cell Collection Device

    Time frame: Through the end of the study-about 9 months

    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

Other outcomes

  1. Interim assessment of number of subjects with each diagnosis

    Time frame: Halfway through the study at about 4 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Keith Fiman, M.D.

CONTACT

[email protected]

713-305-1074

Melissa Tuck, M.S.

CONTACT

[email protected]

734-358-0587

Sponsors and collaborators

Lead sponsor

Cyted Health Inc

Industry

Registry information

Official study title

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

Acronym: DETECT-ME

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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