N/A
N=122
Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy
Barrett Syndrome · Barrett's Syndrome · Barrett's Esophagus · Barrett Esophagus · Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00795184 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. — 34.2; 41.7; 62.5; 75.8 percentage of lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Imaging procedures (NBI) (Device); HDWLE (Device); pCLE (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mauna Kea Technologies
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. |
34.2; 41.7; 62.5; 75.8; 68.3; 45.0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients with documented or suspected Barrett's esophagus presenting for endoscopy
- Age > 18 years
- Ability to provide written, informed consent
Exclusion Criteria
- Presence of erosive esophagitis
- Inability to obtain biopsies due to anticoagulation, varices, etc.
- Allergy to fluorescein, pregnancy
- Presence of an esophageal mass other than small 10mm or less nodules
- Renal insufficiency
Data sourced from ClinicalTrials.gov (NCT00795184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.