Barrett EsophagusDETECT-MENCT06803927
Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples
An observational study of Barrett Esophagus, run by Cyted Health Inc at 1 site in United States.
Trial 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a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Barrett's Esophagus Test (LDT)
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects scheduled for EGD (upper endoscopy) that meet the eligibility criteria at recruiting centers.
Who may be able to join
None listed.
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Gastroenterology Practice
Cordova, Tennessee, 38138
About this study
Official title: Non-Endoscopic Detection of Barrett's Esophagus and Esophageal Neoplasia 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.
- Conditions
- Barrett Esophagus
- Being tested
- Barrett's Esophagus Test (LDT)
- Keywords
- Endosign® Cell Collection Device, Barretts Esophagus
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Barrett's Esophagus Test (LDT) | |
| Barrett's Esophagus | Subjects with known Barrett's esophagus with or without dysplasia/cancer identified or confirmed (surveillance) via a standard of care endoscopy Receives: Device: Barrett's Esophagus Test (LDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Sample collection prior to standard of care endoscopy
Secondary outcomes (3)
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
Measured: At the Baseline Visit
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.
Measured: At study completion, about 1.5 years
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.
Measured: Sample collection prior to standard of care endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start5 Feb 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyted Health Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Co-Lead Investigator, Principal investigator, University of North CarolinaCo-Lead Investigator, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803927
- Sponsor's protocol ID
- ENDOEXT-28
- Acronym
- DETECT-ME
- Status last verified
- Jul 2026
- First submitted
- 22 Jan 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Endoscopic Detection of Barrett's Esophagus and Esophageal Neoplasia Using Methylation Biomarkers on Endosign® Cell Collection Device Samples
- ClinicalTrials.gov ID
- NCT06803927
- Acronym / sponsor ID
- DETECT-ME / ENDOEXT-28
- Conditions
- Barrett Esophagus
- Keywords
- Endosign® Cell Collection Device, Barretts Esophagus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Cyted Health IncIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Risk Screening without Barrett's Esophagus-closed 11/2025 | – | Device: Barrett's Esophagus Test (LDT)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 | – | Device: Barrett's Esophagus Test (LDT)Subjects with known Barrett's esophagus with or without dysplasia/cancer identified or confirmed (surveillance) via a standard of care endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects scheduled for EGD (upper endoscopy) that meet the eligibility criteria at recruiting centers.
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Barrett's Esophagus, High Risk Screening without Barrett's Esophagus-closed 11/2025 |
Primary outcome
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. 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.
3 secondary outcomes
Assess subject self-reported experience with the EndoSign Cell Collection Device
Time frame: At the Baseline Visit
Proportion of Subjects meeting Sample Assay Requirements
Time frame: At study completion, about 1.5 years
Performance of BE Test by Prague, Histopathology grade and Seattle Protocol Adherence.
Time frame: Sample collection prior to standard of care endoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Co-Lead Investigator principal investigator
University of North Carolina
Co-Lead Investigator principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett Esophagus, run by Cyted Health Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Tuck, M.S. (734-358-0587, m.tuck@cytedhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.