Clinical trial · Interventional
Confocal Endomicroscopy for Barrett's Esophagus
Confocal Laser Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Associated Neoplasia
NCT00487695CI-TRIAL-00052384CEBEcompletedPhase 3Results postedClinicalTrials.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 determine if confocal laser endomicroscopy (CLE) can improve detection of Barrett's esophagus, dysplasia, and early esophageal cancer.
Conditions
Conditions (2)
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 | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| confocal laser endomicroscopy (CLE) | Device | — | UNRESOLVED |
| standard endoscopy (EGD) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CLE followed by standard EGD
- description
- Participants are randomized to have either confocal laser endomicroscopy (CLE) or standard endoscopy (EGD) first. Then 6 weeks later, they have the other procedure. This arm is for patients randomized to CLE followed by standard EGD
- interventionNames
- Device: confocal laser endomicroscopy (CLE)
- Device: standard endoscopy (EGD)
- type
- ACTIVE_COMPARATOR
- label
- standard EGD followed by CLE
- description
- Patients are randomized to either have standard endoscopy (EGD)or confocal laser endomicroscopy (CLE) first. The second procedure is then completed 6 weeks later. This arm is for patients who had standard endoscopy first.
- interventionNames
- Device: confocal laser endomicroscopy (CLE)
- Device: standard endoscopy (EGD)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Barrett's esophagus or suspected Barrett's-associated neoplasia * Age \> 18 * Able to give informed consent Exclusion Criteria: * Known advanced malignant disease * Allergy to the fluorescent contrast agent fluorescein sodium * Coagulopathy or bleeding disorder
References
Publications (1)
- RESULTDunbar KB, Okolo P 3rd, Montgomery E, Canto MI. Confocal laser endomicroscopy in Barrett's esophagus and endoscopically inapparent Barrett's neoplasia: a prospective, randomized, double-blind, controlled, crossover trial. Gastrointest Endosc. 2009 Oct;70(4):645-54. doi: 10.1016/j.gie.2009.02.009. Epub 2009 Jun 25. PMID 19559419