Pilot Study for IVLCM in Barrett's Esophagus

This study is testing a new device called the IVLCM tethered capsule (in-vivo laser capture microdissection) for people with Barrett's Esophagus. The goal is to see if this device can safely collect small tissue samples from your esophagus. The IVLCM tethered capsule is swallowed and uses light (optical coherence tomography or OCT) to create detailed images of your esophagus. If an abnormal area is seen, a small laser captures a tiny piece of tissue onto the capsule. These samples can then be studied to better understand the risk of esophageal cancer. The study aims to enroll 30 participants and will measure how many people can have tissue samples collected using this new technique over 5 months. You can join if you are over 18, have Barrett's Esophagus, and can give informed consent. You cannot join if you are pregnant or taking certain medications like anti-platelets or anti-coagulants.

Study design
This is an interventional pilot study aiming to enroll 30 participants. The study is not randomized or blinded.
What's involved
You would swallow the IVLCM tethered capsule, which then captures tissue samples. The primary endpoint is measured at 5 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 5 months, indicating follow-up for at least that duration.

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NCT03830801

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

Recruiting
NAAges 18+InterventionalDevice feasibility
Massachusetts General Hospital
~30 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:IVLCM tethered capsule

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of participants from which we will be able to collect biopsy samples using IVLCM technique
Measured over 5 months
Barrett Esophagus
1 sites across 1 states
Massachusetts1
  • Gary Tearney, MD., PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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Eligibility criteria

Inclusion

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.

Exclusion

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
  • 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