|

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

RECRUITINGN/ASponsored by Massachusetts General Hospital
Actively Recruiting
PhaseN/A
SponsorMassachusetts General Hospital
Started2017-12-06
Est. completion2027-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Barrett EsophagusCancer

Locations1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114
Anita Chung, RN617-643-6092Tearneylabtrials@partners.org

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.