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

Recruiting now · Not applicable

Conditions studied: Barrett Esophagus

In brief

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.

Key facts

Study ID

NCT03830801

Run by

Massachusetts General Hospital

People needed

30

Starts

2017-12-06

Expected to finish

2028-12-01

Last updated by the study team

2025-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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