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NCT02106910 · ClinicalTrials.gov registry record · NA
Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 138
- Enrollment target
NCT02106910 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 138 participants.
The verdict
NCT02106910, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 138 participants
- Enrollment target
Study Summary
Subjects presenting to University of North Carolina at Chapel Hill (UNC) Hospitals for routine endoscopic surveillance examinations for current Barrett's Esophagus (BE) or after successful radiofrequency ablation (RFA) of dysplastic Barrett's Esophagus (BE) will be offered enrollment in the study. After informed consent, and the same day as the endoscopic procedure, the subject will undergo administration of the Cytosponge assay. The patient will then undergo routine endoscopic surveillance, using a standard Seattle biopsy surveillance protocol. The Cytosponge will be placed in fixative and shipped to the Fitzgerald laboratory at the University of Cambridge for processing according to their established protocols. Tissue biopsies will undergo standard processing and Hematoxylin and Eosin (H\&E) staining, with assessment by expert gastrointestinal pathologists at UNC. The primary outcome variables will be sensitivity and specificity of the novel assay, compared against the gold standard of the presence of recurrent BE as detected by upper endoscopy with biopsies. Secondary outcomes include acceptability of the nonendoscopic assay to the patient (assessed by a standardized tool, the Impact of Events Scale, as well as a visual analogue scale), and likelihood of assay positivity as a function of amount of residual disease (as measured by Prague criteria).
Interventions
- DEVICE Cytosponge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2014-10-27 |
| Est. Completion | 2018-08-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02106910
The ClinicalTrials.gov registry entry for NCT02106910 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cytosponge is the first listed.
NCT02106910 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02106910 about?
NCT02106910 is a clinical study titled "Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy". Subjects presenting to University of North Carolina at Chapel Hill (UNC) Hospitals for routine endoscopic surveillance examinations for current Barrett's Esophagus (BE) or after successful radiofrequency ablation (RFA) of dysplastic Barrett's Esophagus (BE) will be offered enrollment in the study. A...
What is the current status of trial NCT02106910?
This trial is currently completed. It is a NA study. The enrollment target is 138 participants. The study started on 2014-10-27. Estimated completion is 2018-08-14.
What interventions are being tested in trial NCT02106910?
The interventions under investigation include: Cytosponge (DEVICE).
Who is sponsoring clinical trial NCT02106910?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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