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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03830801
The ClinicalTrials.gov registry entry for NCT03830801 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,564-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (99% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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