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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

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

Qualifiers

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

Treatments tested in this trial

  • IVLCM tethered capsule

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator