NvisionVLE™ Registry System Registry

Esophagogastroduodenoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215291
• Other study ID #: 13_02
• Status: Completed
• First received: July 31, 2014
• Last updated: March 27, 2018
• Start date: July 2014
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: NinePoint Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: January 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Esophagogastroduodenoscopy

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	VA Boston Health Care System	Boston	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Methodist Dallas Medical Center	Dallas	Texas
United States	Geisinger	Danville	Pennsylvania
United States	Mayo Clinic	Jacksonville	Florida
United States	Ochsner Health System	Kenner	Louisiana
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	North Shore/ LIJ	Long Island City	New York
United States	University of Southern California	Los Angeles	California
United States	Univeristy of South Alabama	Mobile	Alabama
United States	Columbia Univeristy	New York	New York
United States	Weill Cornell Medical College/NewYork-Presbyterian Hospital	New York	New York
United States	University of California Irvine	Orange	California
United States	Florida Hospital	Orlando	Florida
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
NinePoint Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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