Not a traditional drug phase: IVLCM tethered capsule for Barrett Esophagus
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.
Official registry: https://clinicaltrials.gov/study/NCT03830801 · Massachusetts General Hospital · enrollment listed as 30
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are IVLCM tethered capsule. The registry lists allocation as na. 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.
They plan to enroll about 30 people at Boston. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus
Interventions: IVLCM tethered capsule
Primary outcome (registry wording): The number of participants from which we will be able to collect biopsy samples using IVLCM technique
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Participants must have a current or prior diagnosis of Barrett's Esophagus
- Participants must be over the age of 18
Who the registry excludes
- 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
Public study contact (from the registry)
Anita Chung, RN
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Massachusetts General Hospital — Boston, Massachusetts (recruiting)
FAQ about this NCT record
Is NCT03830801 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT03830801?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT03830801?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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