NvisionVLE™ Registry System Registry

NinePoint Medical

Status: Completed

Conditions: Esophagogastroduodenoscopy

Study type: Observational

Funder types: Industry

Identifiers

NCT02215291

13_02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

1,000 participants in 1 patient group

Patients undergoing EGD or esophagoscopy

Description:

The cohort includes patients undergoing EGD or esophagoscopy for initial diagnosis or initial staging and mapping, surveillance of non-treated disease, and treatment (initial or ongoing) or post-treatment surveillance