Clinical trial · Interventional
Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy
NCT00795184CI-TRIAL-00022001DONTBIOPCEcompletedN/AResults 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)
This study will collect data from patients routinely undergoing a endoscopic surveillance and Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Barrett Esophagus | — | UNRESOLVED | — |
| Barrett's Esophagus | — | UNRESOLVED | — |
| Barrett's Syndrome | — | UNRESOLVED | — |
| Barrett Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDWLE | Device | — | UNRESOLVED |
| Imaging procedures (NBI) | Device | — | UNRESOLVED |
| pCLE | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Imaging Procedures HDWLE first NBI second and pCLE
- description
- All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.
- interventionNames
- Device: Imaging procedures (NBI)
- Device: HDWLE
- Device: pCLE
- type
- OTHER
- label
- Imaging Procedures NBI first HDWLE second and pCLE
- description
- All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.
- interventionNames
- Device: Imaging procedures (NBI)
- Device: HDWLE
- Device: pCLE
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with documented or suspected Barrett's esophagus presenting for endoscopy 2. Age \> 18 years 3. Ability to provide written, informed consent Exclusion Criteria: 1. Presence of erosive esophagitis 2. Inability to obtain biopsies due to anticoagulation, varices, etc. 3. Allergy to fluorescein, pregnancy 4. Presence of an esophageal mass other than small 10mm or less nodules 5. Renal insufficiency
References
Publications (1)
- RESULTSharma P, Meining AR, Coron E, Lightdale CJ, Wolfsen HC, Bansal A, Bajbouj M, Galmiche JP, Abrams JA, Rastogi A, Gupta N, Michalek JE, Lauwers GY, Wallace MB. Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2011 Sep;74(3):465-72. doi: 10.1016/j.gie.2011.04.004. Epub 2011 Jul 13. PMID 21741642