NvisionVLE™ Registry System Registry

Esophagogastroduodenoscopy Clinical Trial

Official title: High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging Registry

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Esophagogastroduodenoscopy

• NCT number: NCT02215291
• Study type: Observational [Patient Registry]
• Source: NinePoint Medical
• Status: Completed
• Start date: July 2014
• Completion date: January 2018