Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Carcinoma

Adenocarcinoma

Syndrome

Barrett Esophagus

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

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.

Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order.

Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete.

Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed.

After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites.

Imaging procedures (NBI)

HDWLE

pCLE

Prateek Sharma, MD

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.

This is a longitudinal observational study were imaging procedures are allocated in a random order to directly address the low sensitivity and specificity of enhanced macroscopic endoscopic imaging devices by determining whether probe-based Confocal Laser Endomicroscopy (pCLE), as a supplement to Narrow Band Imaging (NBI) can further improve sensitivity and specificity to a level that would be acceptable to avoid random biopsy, and better direct biopsy of suspicious areas. The study is also addressing pCLE as a supplement to standard white light endoscopy and random biopsy alone. In fact, the study is powered to evaluate per lesion sensitivity and specificity of confocal imaging as applied to lesions identified by white light endoscopy. Therefore, the study addresses the shortcomings of standard white light endoscopy (high number of random biopsies, less than ideal directed biopsy of suspicious areas) and the primary shortcomings of Narrow Band Imaging (NBI) (low specificity with resultant high false positives, again resulting in many unnecessary biopsies).

Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.

Cellvizio Inc.

Emissary International LLC

Mauna Kea Technologies

Group 1

Age, Continuous

Sex: Female, Male

France

United States

Germany

Region of Enrollment

Christophe Bailleul

Sensitivity

Specificity

NBI (Narrow Band Imaging)

HDWLE+NBI+pCLE

HDWLE+pCLE

HDWLE+NBI

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.

HDWLE First NBI Second and pCLE

NBI First HDWLE Second and pCLE

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy	NCT00795184	Barrett Syndrom... Barrett's Syndr... Barrett's Esoph... Barrett Esophag... Adenocarcinoma	Imaging procedu... HDWLE pCLE	18 Years -	Mauna Kea Technologies
Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy	NCT00795184	Barrett Syndrom... Barrett's Syndr... Barrett's Esoph... Barrett Esophag... Adenocarcinoma	Imaging procedu... HDWLE pCLE	18 Years -	Mauna Kea Technologies

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