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NCT06803927 · ClinicalTrials.gov registry record
Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples
A clinical trial of Barrett Esophagus, sponsored by Cyted Health.
- Recruiting
- Registry status
- 700
- Enrollment target
- 1
- Study location
NCT06803927: Recruiting study of Barrett Esophagus, sponsored by Cyted Health.
NCT06803927 is a study of Barrett Esophagus that is actively recruiting participants, run by Cyted Health. The registered enrollment target is 700 participants, below the 3,543-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06803927, a study of Barrett Esophagus, is actively recruiting participants, sponsored by Cyted Health.
- RECRUITING
- Registry status
- 700 participants
- Enrollment target
- 1
- Study location
Study 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a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Barrett's Esophagus Test (LDT)
Study Locations (1)
Tennessee
- Gastroenterology Practice - Cordova
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2025-02-05 |
| Est. Completion | 2026-12 |
What NCT06803927 shows while recruiting
NCT06803927 is an observational study that tracks outcomes without assigning an intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, below the 3,543-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Barrett Esophagus appearing as the primary indexed condition, and to 1 intervention - of which Barrett's Esophagus Test (LDT) is the first listed.
NCT06803927 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06803927 about?
NCT06803927 is a clinical study titled "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...
What is the current status of trial NCT06803927?
This trial is currently recruiting. The enrollment target is 700 participants. The study started on 2025-02-05. Estimated completion is 2026-12.
What conditions does trial NCT06803927 study?
This clinical trial studies the following conditions: Barrett Esophagus.
What interventions are being tested in trial NCT06803927?
The interventions under investigation include: Barrett's Esophagus Test (LDT) (DEVICE).
Who is sponsoring clinical trial NCT06803927?
This trial is sponsored by Cyted Health, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06803927 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Barrett Esophagus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06803927's enrollment target sits among peer trials
700 9th of 32 higher than 24 of 32 other Barrett Esophagus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Barrett Esophagus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
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-
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InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
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Longitudinal Oral Microbiome Sampling for BE
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Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
RECRUITING · NA
-
Obeticholic Acid for Prevention in Barrett's Esophagus
RECRUITING · Phase 2
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