NvisionVLE™ Registry System Registry

NCT02215291 | Completed

• 1 other identifier: 13_02
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Esophagogastroduodenoscopy

Keywords

Undergoing Esophagogastroduodenoscopy (EGD) or endoscopy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NinePoint Medical: lead

Study Sites (18)

Univeristy of South Alabama

Mobile, Alabama, 36688, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Ochsner Health System

Kenner, Louisiana, 70121, United States

Location

VA Boston Health Care System

Boston, Massachusetts, 02132, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

North Shore/ LIJ

Long Island City, New York, 11030, United States

Location

Weill Cornell Medical College/NewYork-Presbyterian Hospital

New York, New York, 10021, United States

Location

Columbia Univeristy

New York, New York, 10032, United States

Location

Geisinger

Danville, Pennsylvania, 17821, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• 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.

  PMID: 31037293 DERIVED

Study Officials

• Michael Smith, MD, MBA

  Temple University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 13, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: January 1, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

US (18)