NCT02215291

NvisionVLE™ Registry System Registry

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: NinePoint Medical · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Esophagogastroduodenoscopy

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-03-01
• Completion: 2018-01-01
• First posted: 2014-08-13
• Last updated: 2018-03-29

Locations

18 sites across 1 country: United States