Capsule-sponge surveillance for ultralong-segment Barrett's esophagus
Official title: Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy
Run by Erasmus Medical Center · NCT06720636 · Data updated 2026-11-12
This tests whether the EndoSign capsule-sponge can detect precancerous changes and early esophageal cancer in adults with ultralong-segment Barrett's esophagus compared with standard endoscopy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 137 (estimated) |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Status | Recruiting |
| Started | February 3, 2025 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | August 12, 2025 |
| Trial ID | NCT06720636 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 years or older with ultralong-segment Barrett's esophagus who are clinically fit for endoscopy and able to give informed consent are ideal candidates.
✕Probably not a fit
Patients with known advanced esophageal tumors, dysphagia, esophageal strictures or varices, recent swallowing-impairing cerebrovascular events, prior ablative treatments for dysplasia, or inability to swallow/consent are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with ultralong-segment Barrett's esophagus will undergo both the EndoSign capsule-sponge test and a standard esophagogastroduodenoscopy (EGD) by an expert endoscopist, and the results will be compared for concordance in detecting dysplasia or esophageal adenocarcinoma. Cells collected by the capsule-sponge will be examined for cellular atypia and stained with p53 immunohistochemistry alongside testing of novel molecular biomarkers. The primary analysis will compare detection rates between the two methods to determine how well the nonendoscopic test matches endoscopic biopsy findings. If concordance is high, the capsule-sponge could offer a less invasive surveillance option for selected patients.
Why it matters
Potential benefit: If successful, the EndoSign capsule-sponge could provide a less invasive, more acceptable way to monitor Barrett's esophagus and reduce the need for repeated endoscopies.
How similar studies have gone: Similar capsule-sponge approaches like the Cytosponge have shown promising results for detecting Barrett's-related changes, but the EndoSign device and its specific biomarker panel are newer and less widely tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any participant 18 years and above, with ultralong-segment Barrett's esophagus and clinically fit for an endoscopy * Ability to provide informed consent Exclusion Criteria: * 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
Where it's running
-
Erasmus Medisch Centrum
Rotterdam, South Holland, Netherlands Recruiting
Study contacts
- Principal investigator: Judith Honing, MSc, PhD — Erasmus Medical Center
- Study coordinator: Anne-Elise C de Groen, MSc
- Email: a.degroen@erasmusmc.nl
- Phone: 003110 703 16 93
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.