NvisionVLE™ Registry System Registry
- Conditions
- Esophagogastroduodenoscopy
- Registration Number
- NCT02215291
- Lead Sponsor
- NinePoint Medical
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
- Patients presenting for an endoscopic examination of the esophagus
- Ability to provide written, informed consent to participate in the Registry
- Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent of patients with endoscopically visible disease/ suspicious areas as determined by the physician Baseline 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.
Percent of patients with VLE visible abnormalities/ suspicious areas as determined by the physician Baseline 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.
Percent of patients with histologically confirmed disease and a breakdown of diseases observed Baseline 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.
Percent of treated patients with endoscopic and VLE identified areas of retained or persistent abnormalities at the first endoscopic evaluation after treatment Baseline 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.
Percent of patients with abnormalities/ suspicious areas identified by the physician as subsquamous visualized on VLE and not seen on endoscopy Baseline 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.
Percent of treated patients undergoing surveillance with endoscopic and VLE areas of recurrent abnormality diagnosed by histology as disease Baseline 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Geisinger
🇺🇸Danville, Pennsylvania, United States
Univeristy of South Alabama
🇺🇸Mobile, Alabama, United States
Ochsner Health System
🇺🇸Kenner, Louisiana, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of California Irvine
🇺🇸Orange, California, United States
VA Boston Health Care System
🇺🇸Boston, Massachusetts, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
North Shore/ LIJ
🇺🇸Long Island City, New York, United States
Columbia Univeristy
🇺🇸New York, New York, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Weill Cornell Medical College/NewYork-Presbyterian Hospital
🇺🇸New York, New York, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States