Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy
NCT ID: NCT06720636
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
137 participants
INTERVENTIONAL
2025-02-03
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Ability to provide informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cyted Health Inc
INDUSTRY
University of Cambridge
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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Judith Honing
Principal Investigator
Principal Investigators
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Judith Honing, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmus Medisch Centrum
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL87577.078.24
Identifier Type: -
Identifier Source: org_study_id
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