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

Sponsor
Erasmus Medical Center
Study ID
NCT06720636
Status
Recruiting
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Conditions

  • Barrett Esophagus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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 Details

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.

Key Dates

First listed
Dec 6, 2024
Start date
Feb 3, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
137 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Study group
    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.

Primary Outcome Measure

Concordance between EndoSign and upper endoscopy to detect dysplasia and/or esophageal adenocarcinoma [ Time Frame: 3 years ]

Central Contacts

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