Status:
RECRUITING
Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions:
Barrett Esophagus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
In Vivo Laser Capture Microdissection (IVLCM). The IVLCM tethered capsule is identical to those used in current approved OCT TCE studies.The capsule is swallowed by the patient and then, in real time,...
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
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03830801
Start Date
December 6 2017
End Date
December 1 2028
Last Update
October 22 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114