Recruiting

ULSBECapsule-sponge Test for Ultralong-segment Barrett's Esophagus

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

EndoSign

Device
Who is being recruted

Barrett Esophagus+3

+ Digestive System Diseases

+ Esophageal Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorErasmus Medical Center
Study ContactAnne-Elise C de Groen, MScMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 3, 2025

Actual date on which the first participant was enrolled.

This study is focused on finding a better way to monitor people with a condition called ultralong-segment Barrett's esophagus, which can sometimes lead to a type of cancer called esophageal adenocarcinoma (EAC). Currently, the condition is checked using a procedure called esophagogastroduodenoscopy (EGD), where a doctor looks inside the esophagus with a camera. The study is testing a new method using a device called the Endosign capsule sponge test. This approach might offer a simpler way to check for early signs of cancer, potentially reducing the need for the more invasive EGD procedure. Participants in the study will undergo both the Endosign capsule sponge test and the EGD. The capsule sponge is swallowed and collects cells from the esophagus, which are then analyzed for unusual changes and specific markers, like p53, that could indicate cancer. The study aims to compare the findings from the Endosign test with those from the EGD to see if the new test can reliably detect problems. If successful, this new test could make it easier and less invasive to monitor people with Barrett's esophagus in the future.

Official TitleUltralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy
NCT06720636
Principal SponsorErasmus Medical Center
Study ContactAnne-Elise C de Groen, MScMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

137 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Barrett EsophagusDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesNeoplasmsPrecancerous Conditions

Criteria

2 inclusion criteria required to participate
Any participant 18 years and above, with ultralong-segment Barrett's esophagus and clinically fit for an endoscopy

Ability to provide informed consent

6 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Erasmus Medisch Centrum

Rotterdam, NetherlandsOpen Erasmus Medisch Centrum in Google Maps
Recruiting
One Study Center