Clinical trial · Interventional
Confocal Laser Probe to Treat Barrett's Esophagus
Real-Time Evaluation of Barrett's Esophagus by Confocal Laser Probe-based Microscopy
NCT02852525CI-TRIAL-00023338pCLEcompletedN/AClinicalTrials.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 purpose of this study is to further validate the use of probe-based confocal laser endomicroscopy (pCLE) for the evaluation of Barrett's Esophagus and associated neoplasia in a larger patient base.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Confocal laser endomicroscopy (pCLE) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Confocal laser endomicroscopy (pCLE)
- description
- Patients agreeing to participate in the research study will receive an additional intravenous injection during endoscopy. This dose of 2.5 mg of IV fluorescein will be administered during their EGD. Probe-based microscopy will be used to evaluate the mucosa of the esophagus and GE junction. Photographs will be taken and digitally stored. Biopsies (which are part of the routine diagnosis and surveillance of Barrett's) will be targeted based on the microscopic images. The histologic findings on the biopsy specimens will be compared to the microscopic images to determine the accuracy of the probe-based microscopy in predicting pathology.
- interventionNames
- Device: Confocal laser endomicroscopy (pCLE)
Primary outcomes (1)
- measure
- Sensitivity and Specificity of probe based endomicroscopy as compared to histopathology in diagnosing Barrett's metaplasia
- timeFrame
- 30 minutes up to an hour on average after undergoing endoscopy
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Must be greater than 18 years of age * currently undergoing EGD * previous diagnosis of Barrett's Esophagus * long-standing GERD of greater than 5 years * undergoing therapy for previously diagnosed Barrett's Esophagus Exclusion Criteria: * Under 19 years of age
References
Publications (0)
Data not yet available
No reference posted for this study.