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Clinical Trials in the Netherlands / NCT06720636
Recruiting Not applicable

Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy

NCT06720636 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Erasmus Medical Center
Phase
Not applicable
Started
2025-02-03
Last updated
2025-08-12

Condition(s) studied

Barrett Esophagus

Investigational drug(s) / intervention(s)

EndoSign

EndoSign: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Concordance between EndoSign and upper endoscopy to detect dysplasia and/or esophageal adenocarcinoma — 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.

Trial sites (1)

FacilityCityRegionStatus
Erasmus Medisch Centrum Rotterdam South Holland Recruiting

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Other trials for the same condition

Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma Recruiting
Trans-Oral Sampling as an Alternative Surveillance of Barrett's Esophagus Pilot Active, not recruiting
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project. Recruiting
A Multicenter Prospective Cohort Study Comparing Random Biopsies Versus Wide-Area Transepithelial Brush-Sampling (WATS) for Surveillance of Barrett's Esophagus, the WATS-EURO2 Study Recruiting
C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study. Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06720636 on ClinicalTrials.gov ↗ ← All trials in the Netherlands