Barrett EsophagusULSBENCT06720636
Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy
A study testing EndoSign in people with Barrett Esophagus, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the Endosign capsule sponge test as a novel surveillance method in patients with an ultralong-segment Barrett's esophagus. 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?
- EndoSign
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Feb 2025to Sep 2027
- Phase
- Interventional
- 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
Who may be able to join
- Any participant 18 years and above, with ultralong-segment Barrett's esophagus and clinically fit for an endoscopy
- Ability to provide informed consent
Who cannot join
- Individuals with a diagnosis of an oro-pharynx, esophageal or gastro-esophageal tumor (T2 staging and above), or symptoms of dysphagia
- Esophageal varices or stricture requiring dilatation of the esophagus
- Individuals who have had a cerebrovascular event < 6 months prior where their swallowing has been affected
- Patients who have had previous treatments such as Photodynamic therapy (PDT), Radiofrequency ablation (RFA) or Argon Plasma Coagulation (APC) for dysplastic Barrett's esophagus
- Participants who are unable to provide informed consent
- Participants under age 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medisch Centrum
Rotterdam, South Holland, 1315 GD
Anne-Elise C de Groen, MSc in Medicine, +31 6 29 56 33 36, a.degroen@erasmusmc.nl
About this study
The purpose of this study is to evaluate the Endosign capsule sponge test as a novel surveillance method in patients with an ultralong-segment Barrett's esophagus.
Read the detailed description
In this study we will investigate the concordance between the Endosign capsule sponge test and esophagogastroduodenoscopy (EGD) by an expert endoscopist to detect dysplasia and/or esophageal adenocarcinoma (EAC) in patients with an ultralong-segment Barrett's esophagus. Patients will receive both the Endosign test and an EGD, after which we will compare both outcomes. To detect dysplasia and/or EAC on the cells collected by the Endosign test, we will look at cellular atypia and use p53 immunohistochemistry and novel biomarkers. In the future the Endosign test could perhaps replace EGD in the surveillance of Barrett's esophagus patients.
- Conditions
- Barrett Esophagus
- Being tested
- EndoSign
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoSignDevice
The EndoSign cell collection device is a non-endoscopic capsule sponge device used to collect pan-esophageal samples.
The Endosign procedure consists of an expandable, spherical mesh, which is attached to a string and contained within a soluble capsule. Seven minutes after swallowing (once the capsule has dissolved), the spherical mesh, which measures around 3cm in diameter is retrieved by pulling on the string. Upon retrieval the capsule-sponge scrapes against the surface of the top of the stomach and esophagus and collects epithelial cells. The capsule-sponge sample is then placed into a preservative fluid and the specimen is processed for molecular tests.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Subjects will receive the EndoSign test prior to their scheduled clinically indicated upper endoscopy by an expert endoscopist, per routine standard of care. Additional biopsies will be taken and 10cc of blood will be collected from the cannula used for sedation. Subjects will also receive three questionnaires regarding baseline characteristics, gastrointestinal symptoms and acceptability. Receives: Device: EndoSign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between EndoSign and upper endoscopy to detect dysplasia and/or esophageal adenocarcinoma
We will determine the concordance between the EndoSign test and upper endoscopy by an expert endoscopist to detect dysplasia and/or esophageal adenocarcinoma in patients with an ultralong-segment Barrett's esophagus.
Measured: 3 years
Secondary outcomes (6)
Patient rating of both the EndoSign procedure and upper endoscopy on an experience scale
Patients with an ultralong Barrett esophagus will rate their experience with both the Endosign procedure and endoscopy on a scale from 1 - 10, with 1 being the worst experience ever and 10 the best experience ever. These results will be compared to assess which procedure is generally more acceptable to patients.
Measured: 3 years
Sensitivity & specificity
To determine the sensitivity and specificity of the EndoSign to detect any form of dysplasia or esophageal adenocarcinoma in a cohort of ultralong-segment Barrett's esophagus patients.
Measured: 3 years
Additional value of p53 immunohistochemistry
To determine the additional value of p53 immunohistochemistry in risk stratifying patients with ultralong-segment Barrett's esophagus.
Measured: 3 years
Accuracy of a new risk stratification model for neoplastic progression
We will determine the accuracy of a newly developed risk stratification model that predicts which patients with an ultralong-segment Barrett's esophagus have the highest chance of neoplastic progression. We will use both clinical risk factors and p53 immunohistochemistry.
Measured: 3 years
Accuracy of a new shallow Whole Genome Sequencing assay to predict neoplastic progression
We will determine the accuracy of a new shallow Whole Genome Sequencing (sWGS) assay for predicting neoplastic progression in patients with an ultralong Barrett's esophagus.
Measured: 3 years
Validation of the sensitivity of a current methylation-based sequencing approach to predict neoplastic progression
We aim to validate the sensitivity of a current sequencing approach using both methylation and genome instability to detect neoplastic progression in patients with an ultralong Barrett's esophagus.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start3 Feb 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cyted Health Inc, University of Cambridge
- Responsible party
- Principal investigator, Judith Honing, Erasmus Medical Center
- Investigators
- Judith Honing, MSc, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720636
- Sponsor's protocol ID
- NL87577.078.24
- Acronym
- ULSBE
- Status last verified
- Aug 2025
- First submitted
- 21 Nov 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy
- ClinicalTrials.gov ID
- NCT06720636
- Acronym / sponsor ID
- ULSBE / NL87577.078.24
- Conditions
- Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Cyted Health Inc, University of Cambridge
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 6 Dec 2024 (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.
The purpose of this study is to evaluate the Endosign capsule sponge test as a novel surveillance method in patients with an ultralong-segment Barrett's esophagus.
Detailed description
In this study we will investigate the concordance between the Endosign capsule sponge test and esophagogastroduodenoscopy (EGD) by an expert endoscopist to detect dysplasia and/or esophageal adenocarcinoma (EAC) in patients with an ultralong-segment Barrett's esophagus. Patients will receive both the Endosign test and an EGD, after which we will compare both outcomes. To detect dysplasia and/or EAC on the cells collected by the Endosign test, we will look at cellular atypia and use p53 immunohistochemistry and novel biomarkers. In the future the Endosign test could perhaps replace EGD in the surveillance of Barrett's esophagus patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: EndoSignSubjects will receive the EndoSign test prior to their scheduled clinically indicated upper endoscopy by an expert endoscopist, per routine standard of care. Additional biopsies will be taken and 10cc of blood will be collected from the cannula used for sedation. Subjects will also receive three questionnaires regarding baseline characteristics, gastrointestinal symptoms and acceptability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any participant 18 years and above, with ultralong-segment Barrett's esophagus and clinically fit for an endoscopy
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Individuals with a diagnosis of an oro-pharynx, esophageal or gastro-esophageal tumor (T2 staging and above), or symptoms of dysphagia
- Esophageal varices or stricture requiring dilatation of the esophagus
- Individuals who have had a cerebrovascular event < 6 months prior where their swallowing has been affected
- Patients who have had previous treatments such as Photodynamic therapy (PDT), Radiofrequency ablation (RFA) or Argon Plasma Coagulation (APC) for dysplastic Barrett's esophagus
- Participants who are unable to provide informed consent
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 |
|---|---|---|
| EndoSignThe EndoSign cell collection device is a non-endoscopic capsule sponge device used to collect pan-esophageal samples. The Endosign procedure consists of an expandable, spherical mesh, which is attached to a string and contained within a soluble capsule. Seven minutes after swallowing (once the capsule has dissolved), the spherical mesh, which measures around 3cm in diameter is retrieved by pulling on the string. Upon retrieval the capsule-sponge scrapes against the surface of the top of the stomach and esophagus and collects epithelial cells. The capsule-sponge sample is then placed into a preservative fluid and the specimen is processed for molecular tests. | Device | Study group |
Primary outcome
Concordance between EndoSign and upper endoscopy to detect dysplasia and/or esophageal adenocarcinoma
Time frame: 3 years
We will determine the concordance between the EndoSign test and upper endoscopy by an expert endoscopist to detect dysplasia and/or esophageal adenocarcinoma in patients with an ultralong-segment Barrett's esophagus.
6 secondary outcomes
Patient rating of both the EndoSign procedure and upper endoscopy on an experience scale
Time frame: 3 years
Sensitivity & specificity
Time frame: 3 years
Additional value of p53 immunohistochemistry
Time frame: 3 years
Accuracy of a new risk stratification model for neoplastic progression
Time frame: 3 years
Accuracy of a new shallow Whole Genome Sequencing assay to predict neoplastic progression
Time frame: 3 years
Validation of the sensitivity of a current methylation-based sequencing approach to predict neoplastic progression
Time frame: 3 years
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 12 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Barrett Esophagus
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Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
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RecruitingObservational study
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
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Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
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Impact of RFA on Esophageal Distensibility and Mucosal Impedance
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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.
Judith Honing, MSc, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoSign in people with Barrett Esophagus, run by Erasmus Medical Center at 1 site in Netherlands.
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 2 inclusion and 6 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 12 Aug 2025. 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 Netherlands. 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 Anne-Elise C de Groen, MSc (003110 703 16 93, a.degroen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between EndoSign and upper endoscopy to detect dysplasia and/or esophageal adenocarcinoma (time frame: 3 years). 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 12 Aug 2025.