About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
IVLCM tethered capsule
DeviceObtaining biopsies for genomic sequencing of BE for the assessment of EAC risk using IVLCM tethered capsule
Treatment groups
Trial outcomes
Primary outcomes
The number of participants from which we will be able to collect biopsy samples using IVLCM technique
We will measure the number of subjects from which we will be able to collect biopsy samples using IVLCM technique
Sponsors and contacts
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Massachusetts General Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator