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NCT03830801 · ClinicalTrials.gov registry record · NA
Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus
A NA study of Barrett Esophagus, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03830801: Recruiting NA study of Barrett Esophagus, sponsored by Massachusetts General Hospital.
NCT03830801 is a NA study of Barrett Esophagus that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 3,564-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03830801, a NA study of Barrett Esophagus, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
We will measure the number of subjects from which we will be able to collect biopsy samples using IVLCM technique
Conditions Studied
Interventions
- DEVICE IVLCM tethered capsule
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-12-06 |
| Est. Completion | 2028-12 |
| Phase | NA |
What NCT03830801 shows while recruiting
NCT03830801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 3,564-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Barrett Esophagus appearing as the primary indexed condition, and to 1 intervention - of which IVLCM tethered capsule is the first listed.
NCT03830801 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03830801 about?
NCT03830801 is a clinical study titled "Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's 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 tether...
What is the current status of trial NCT03830801?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2017-12-06. Estimated completion is 2028-12.
What conditions does trial NCT03830801 study?
This clinical trial studies the following conditions: Barrett Esophagus.
What interventions are being tested in trial NCT03830801?
The interventions under investigation include: IVLCM tethered capsule (DEVICE).
Who is sponsoring clinical trial NCT03830801?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03830801 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Barrett Esophagus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03830801's enrollment target sits among peer trials
30 28th of 32 higher than 4 of 32 other Barrett Esophagus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Barrett Esophagus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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