Clinical trial NCT02215291: NvisionVLE™ Registry System Registry
Official title: High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagogastroduodenoscopy
Keywords: Undergoing Esophagogastroduodenoscopy (EGD) or endoscopy
Lead sponsor: NinePoint Medical
Sponsor class: INDUSTRY
First posted: 2014-08-13
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percent of patients with endoscopically visible disease/ suspicious areas as determined by the physician
timeFrame: Baseline
measure: Percent of patients with VLE visible abnormalities/ suspicious areas as determined by the physician
timeFrame: Baseline
measure: Percent of patients with histologically confirmed disease and a breakdown of diseases observed
timeFrame: Baseline
measure: Percent of treated patients with endoscopic and VLE identified areas of retained or persistent abnormalities at the first endoscopic evaluation after treatment
timeFrame: Baseline
measure: Percent of treated patients undergoing surveillance with endoscopic and VLE areas of recurrent abnormality diagnosed by histology as disease
timeFrame: Baseline
measure: Percent of patients with abnormalities/ suspicious areas identified by the physician as subsquamous visualized on VLE and not seen on endoscopy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Univeristy of South Alabama
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Kenner
country: United States
facility: Ochsner Health System
state: Louisiana
city: Boston
country: United States
facility: VA Boston Health Care System
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Long Island City
country: United States
facility: North Shore/ LIJ
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College/NewYork-Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Columbia Univeristy
state: New York
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: Temple University Hospital
name: Michael Smith, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.