Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 6 Dec 2017
- Expected to end
- Dec 2028
- Type of study
- Interventional
- Treatments tested
- IVLCM tethered capsule
- Record updated
- 10 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Participants with a history of hemostasis disorders
- Participants with a know history of esophageal varices
- Participants who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure
- Participants above 80 years of age
- Pregnant women
- Participants with esophageal strictures, resulting in a luminal diameter smaller than the diameter of the capsule
Where in United States
- Massachusetts General HospitalBoston, United StatesContact: Anita Chung, RNTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- IVLCM tethered capsule for biopsiesTreatment being tested
IVLCM tethered capsule for obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk.
Treatment: IVLCM tethered capsule
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 10 November 2026