RecruitingNot ApplicableNCT03830801

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


Sponsor

Massachusetts General Hospital

Enrollment

30 participants

Start Date

Dec 6, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new technique that combines a special type of optical camera (OCT — similar to a tiny microscope using light) with laser technology during an upper endoscopy, to precisely capture tissue samples from the food pipe (esophagus) in patients with a condition called Barrett's esophagus, which can sometimes lead to cancer. **You may be eligible if...** - You have a current or prior diagnosis of Barrett's esophagus (a precancerous change in the lining of the food pipe) - You are over 18 years old - You are able to give informed consent **You may NOT be eligible if...** - You are pregnant - You are taking blood thinners, anti-platelet medications (like aspirin in high doses), or NSAIDs (such as ibuprofen) at the time of the procedure - You have a history of a blood clotting disorder - You have a narrowing of the esophagus (stricture) that is too tight for the capsule used in the procedure - You have a history of esophageal varices (swollen veins in the esophagus) - You are older than 80 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIVLCM tethered capsule

Obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk using IVLCM tethered capsule


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT03830801


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