NCT03830801 Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus
| NCT ID | NCT03830801 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Barrett Esophagus |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2017-12-06 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2017-12-06 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Gary Tearney, MD., PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT03830801 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Barrett Esophagus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03830801 currently recruiting?
Yes, NCT03830801 is actively recruiting participants. Contact the research team at Tearneylabtrials@partners.org for enrollment information.
Where is the NCT03830801 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03830801 clinical trial?
NCT03830801 is sponsored by Massachusetts General Hospital. The principal investigator is Gary Tearney, MD., PhD at Massachusetts General Hospital. The trial plans to enroll 30 participants.