IVLCM: Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus
Intervencionista
Fase no especificada
Mass General Hospital
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 isolation of aberrant esophageal tissues using a swallowable capsule, this technology has the potential to solve the major problems that currently prohibit adequate BE screening and prevention of Esophageal Adenocarcinoma EAC.
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Categoría de tratamiento
Dispositivo
Erforderliche Mutationen
Ninguna
Ensayo iniciado
2017-12-06
Última actualización por el patrocinador
2025-10-22
Finalización estimada
2027-12-01
Elegibilidad
Criterios de inclusión
* 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.
Criterios de exclusión
* 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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Detalles del diseño
AsignaciónN/A
Modelo de intervenciónSingle Group Assignment
EnmascaramientoNone (Open Label)
Número a inscribir30
Brazos e Intervenciones
Brazos
Intervenciones
Tipo: Experimental
Descripción: IVLCM tethered capsule for obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk.
Intervenciones:
IVLCM tethered capsule
Medidas de resultado
Medidas de resultado primarias
The number of participants from which we will be able to collect biopsy samples using IVLCM technique5 months
We will measure the number of subjects from which we will be able to collect biopsy samples using IVLCM technique
Medidas de resultado secundarias
Ninguno
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