Clinical trial · Observational
Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus?
NCT01373125CI-TRIAL-00019196completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators propose a study comparing the morphological and functional aspects of the neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE) to that of native squamous epithelium in normal controls as well as gastroesophageal reflux disease (GERD), non-Barrett's Esophagus (BE) subjects.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| Gastroesophageal Reflux Disease (GERD) | — | UNRESOLVED | — |
| Intestinal Metaplasia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- Radiofrequency Ablation (RFA)
- description
- Participants in this group are greater than or equal to 12 months status post radiofrequency ablation (RFA).
- label
- Radiofrequency Ablation Longitudinal (RFAL)
- description
- Participants in this group are part of a longitudinal portion of the study and are enrolled prior to their first radiofrequency ablation procedure and followed at 6 and 12 months after completion of RFA.
- label
- Gastroesophageal Reflux Disease (GERD)
- description
- Participants in this group have been diagnosed with gastroesophageal reflux disease.
- label
- Asymptomatic Controls (AC)
- description
- Participants in this group are asymptomatic controls and enrolled as part of the comparison group.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion: Eligible subjects will be mentally competent women and men between the ages of 18-80, able to speak and read English and who meet one of the following criteria: * Two or greater cm of dysplastic Barrett's Esophagus (BE), who will undergo or have undergone radiofrequency ablation (RFA) for BE at the University of North Carolina, Chapel Hill (UNC), or * Diagnosed with gastroesophageal reflux disease (GERD) per a GI physician undergoing upper endoscopy (EGD) for other indications at UNC, or * Non-GERD controls per a GI physician with normal esophageal mucosa undergoing upper endoscopy for other indications at UNC. Exclusion: * Subjects with a bleeding diathesis or other contraindication of endoscopic biopsy. * Current use of warfarin, heparin, and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 7 days after EGD). * Pregnant women
References
Publications (0)
Data not yet available
No reference posted for this study.