NvisionVLE™ Registry System Registry

High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging Registry

Prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural data for participating physicians, including, but not limited to, imaging data, clinical utility data, demographics, pathology, treatment, and surveillance.

Study Overview

• Status: Completed
• Conditions: Esophagogastroduodenoscopy

Detailed Description

This is a prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural data for participating physicians, including, but not limited to, imaging data, clinical utility data, demographics, pathology, treatment, and surveillance.

Up to 1000 patients from up to 20 sites nationwide.

There are no protocol defined follow up visits. Patients will undergo an initial baseline Volumetric Laser Endomicroscopy (VLE) procedure. A patient with a negative screening examination may not require additional screening endoscopies. For patients with established disease, further surveillance endoscopies will vary based on the extent of the disease (e.g. every 3 months, every 6 months, annual), which is based on the following American Society for Gastrointestinal Endoscopy (ASGE) guideline: the role of endoscopy in the surveillance of premalignant conditions of the upper GI tract. If patients have additional VLE procedures during the enrollment period, associated data will be collected.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36688
      • Univeristy of South Alabama
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Orange, California, United States, 92868
      • University of California Irvine
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University Of Chicago Medical Center
  • Louisiana
    • Kenner, Louisiana, United States, 70121
      • Ochsner Health System
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02132
      • VA Boston Health Care system
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New York
    • Long Island City, New York, United States, 11030
      • North Shore/ LIJ
    • New York, New York, United States, 10021
      • Weill Cornell Medical College/NewYork-Presbyterian Hospital
    • New York, New York, United States, 10032
      • Columbia Univeristy
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17821
      • Geisinger
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Pittsburgh, Pennsylvania, United States, 15224
      • Western Pennsylvania Hospital
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Up to 20 sites; each site will have the opportunity to enroll up to 100 patients. There will be up to 1000 patients enrolled in the registry.

Description

Inclusion Criteria:

• Patients presenting for an endoscopic examination of the esophagus
• Ability to provide written, informed consent to participate in the Registry

Exclusion Criteria:

• Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	Baseline
Percent of patients with abnormalities/ suspicious areas identified by the physician as subsquamous visualized on VLE and not seen on endoscopy	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

Collaborators and Investigators

• Sponsor: NinePoint Medical
• Investigators: Principal Investigator: Michael Smith, MD, MBA, Temple University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 11, 2014
• First Posted (Estimate): August 13, 2014

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Undergoing Esophagogastroduodenoscopy (EGD) or endoscopy
• Other Study ID Numbers: 13_02