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Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus

RecruitingNAAges 18 Years - anyAllMassachusetts General Hospital
NCT03830801 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The investigators have developed a new technology, termed in-vivo laser capture microdissection (IVLCM), that addresses the limitations of endoscopic biopsy for screening for BE and provides targeted genomic profiling of aberrant tissue for more precise prediction of EAC risk. The device is a tethered capsule endomicroscope (TCE) that implements optical coherence tomography (OCT) to grab 10-mm-resolution, cross-sectional microscopic images of the entire esophagus after the capsule is swallowed. This OCT-based TCE technology is used in unsedated patients to visualize images of BE and dysplastic BE. During the IVLCM procedure, TCE images of abnormal BE tissue are identified in real time and selectively adhered onto the device. When the capsule is removed from the patient, these tissues, targeted based on their abnormal OCT morphology, are sent for genomic analysis. By enabling the precise

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📋 Eligibility rules (as published)
Inclusion Criteria: * Participants must have a current or prior diagnosis of Barrett's Esophagus * Participants must be over the age of 18. * Participants must be able to give informed consent. Exclusion Criteria: * Pregnant women. * Participants who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure. * Participants with a history of hemostasis disorders. * Participants with esophageal strictures, resulting in a luminal diameter smaller than the diameter of the capsule. * Participants with a know history of esophageal varices * Participants above 80 years of age
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What it tests

  • IVLCM tethered capsule
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Where

1 site
Massachusetts General Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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