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NCT03375060 · ClinicalTrials.gov registry record
Histology Post-Endoscopic Eradication Therapy (EET)
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 65
- Enrollment target
NCT03375060: Completed study, sponsored by Northwestern University.
NCT03375060 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 65 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03375060 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 65 participants
- Enrollment target
Study Summary
This study is looking at a cohort of patients who have undergone treatment for Barrett's Esophagus (BE) and who have experienced complete eradication of the disease. The aim of the proposed study is to evaluate the histologic features of the neosquamous epithelium (NSE) following complete eradication of intestinal metaplasia (CE-IM) in patients undergoing routine surveillance biopsies and compare these data to a direct measure of reflux using 24hr pH impedance, to determine the correlation between histology and persistent reflux. These data will allow us to more accurately risk stratify patients for recurrence of BE following EET.
Primary Outcome
A composite histologic score made up of the following criteria: * Eosinophil infiltration (0: none, 1: scattered or focal, 2: diffuse or multifocal) * Dilated intercellular spaces (0: none, 0.5: intercellular spaces seen at 40x focal, 1: intercellular spaces seen at 40x diffuse, 1.5: intercellular spaces seen at 10x focal, 2: intercellular spaces seen at 10x diffuse) * Parakaratosis (0: absent, 2: present) * Ballooning degeneration (0: none, 1: focal, 2: extensive) * Basal cell hyperplasia (0:
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2017-08-02 |
| Est. Completion | 2017-11-05 |
What the finished NCT03375060 record still lists
NCT03375060 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 65 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03375060 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03375060 about?
NCT03375060 is a clinical study titled "Histology Post-Endoscopic Eradication Therapy (EET)". This study is looking at a cohort of patients who have undergone treatment for Barrett's Esophagus (BE) and who have experienced complete eradication of the disease. The aim of the proposed study is to evaluate the histologic features of the neosquamous epithelium (NSE) following complete eradicatio...
What is the current status of trial NCT03375060?
This trial is currently completed. The enrollment target is 65 participants. The study started on 2017-08-02. Estimated completion is 2017-11-05.
Who is sponsoring clinical trial NCT03375060?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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