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

NCT06720636 | Recruiting

• 1 other identifier: NL87577.078.24
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (6)

• Patient rating of both the EndoSign procedure and upper endoscopy on an experience scale

  3 years

• Sensitivity & specificity

  3 years

• Additional value of p53 immunohistochemistry

  3 years

• Accuracy of a new risk stratification model for neoplastic progression

  3 years

• Accuracy of a new shallow Whole Genome Sequencing assay to predict neoplastic progression

  3 years

Study Arms (1)

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.

Device: EndoSign

Interventions

EndoSign DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any participant 18 years and above, with ultralong-segment Barrett's esophagus and clinically fit for an endoscopy
• Ability to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Cyted Health Inc: collaborator
• University of Cambridge: collaborator

Study Sites (1)

Erasmus Medisch Centrum

Rotterdam, South Holland, 1315 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Judith Honing, MSc, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Elise C de Groen, MSc

CONTACT

003110 703 16 93; a.degroen@erasmusmc.nl

Judith Honing, MSc, PhD

CONTACT

003110 703 16 93; j.honing@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 6, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)