NvisionVLE™ Registry System Registry | NCT02215291

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing EGD or esophagoscopy		The cohort includes patients undergoing EGD or esophagoscopy for initial diagnosis or initial staging and mapping, surveillance of non-treated disease, and treatment (initial or ongoing) or post-treatment surveillance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of patients with endoscopically visible disease/ suspicious areas as determined by the physician	No protocol defined follow up visits. Patients will undergo an initial baseline Volumetric Laser Endomicroscopy (VLE) procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.	Baseline
Percent of patients with VLE visible abnormalities/ suspicious areas as determined by the physician	No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.	Baseline
Percent of patients with histologically confirmed disease and a breakdown of diseases observed	No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.	Baseline
Percent of treated patients with endoscopic and VLE identified areas of retained or persistent abnormalities at the first endoscopic evaluation after treatment	No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.	Baseline
Percent of treated patients undergoing surveillance with endoscopic and VLE areas of recurrent abnormality diagnosed by histology as disease	No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.

Eligibility Module

Name	Affiliation	Role
Michael Smith, MD, MBA	Temple University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Univeristy of South Alabama		Mobile	Alabama	36688	United States
University of Southern California

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31037293	Derived	Smith MS, Cash B, Konda V, Trindade AJ, Gordon S, DeMeester S, Joshi V, Diehl D, Ganguly E, Mashimo H, Singh S, Jobe B, McKinley M, Wallace M, Komatsu Y, Thakkar S, Schnoll-Sussman F, Sharaiha R, Kahaleh M, Tarnasky P, Wolfsen H, Hawes R, Lipham J, Khara H, Pleskow D, Navaneethan U, Kedia P, Hasan M, Sethi A, Samarasena J, Siddiqui UD, Gress F, Rodriguez R, Lee C, Gonda T, Waxman I, Hyder S, Poneros J, Sharzehi K, Di Palma JA, Sejpal DV, Oh D, Hagen J, Rothstein R, Sawhney M, Berzin T, Malik Z, Chang K. Volumetric laser endomicroscopy and its application to Barrett's esophagus: results from a 1,000 patient registry. Dis Esophagus. 2019 Nov 13;32(9):doz029. doi: 10.1093/dote/doz029.