Recruiting

Methylation Biomarkers

Sponsor:

Cyted Health Inc

Code:

NCT06803927

Conditions

Barrett Esophagus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Barrett's Esophagus Test (LDT)

Study Details

Brief summary:

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capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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

Conditions

Barrett Esophagus

Study ID

NCT06803927

Start date

Feb 5, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

700 participants

Anticipated

Interventions and Outcome Measures

Arms

High Risk Screening without Barrett's Esophagus-closed 11/2025

Subjects with chronic GERD plus 3 other defined risk factors for Barrett's Esophagus (ACG) (e.g., age >50, male, white, obese, family history) who have had a standard of care endoscopy in which no Barrett's esophagus was identified.

Barrett's Esophagus

Subjects with known Barrett's esophagus with or without dysplasia/cancer identified or confirmed (surveillance) via a standard of care endoscopy

Interventions

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)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Melissa Tuck, M.S.

734-358-0587m.tuck@cytedhealth.com

Keith Fiman, M.D.

713-305-1074k.fiman@cytedhealth.com

Locations

Gastroenterology Practice

Recruiting

Cordova, Tennessee, United States, 38138

More Information

Sponsor

Cyted Health Inc

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • Endosign® Cell Collection Device
  • Barretts Esophagus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cyted Health Inc on 2026-07-29.