IVLCM: Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus
Interventional
Phase not listed
Mass General Hospital
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.
Show Detailed Description
Treatment Category
Device
Required Mutations
None
Trial Started
2017-12-06
Last Updated by Sponsor
2025-10-22
Estimated Completion
2027-12-01
Eligibility
Inclusion Criteria
* 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 Criteria
* 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
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Design Details
AllocationN/A
Intervention ModelSingle Group Assignment
MaskingNone (Open Label)
Number to Enroll30
Arms & Interventions
Arms
Interventions
Type: Experimental
Description: IVLCM tethered capsule for obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk.
Interventions:
IVLCM tethered capsule
Outcome Measures
Primary Outcome Measures
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
Secondary Outcome Measures
None
Interested in participating?
Learn more about this trial and whether you may be eligible to participate.