NvisionVLE™ Registry System Registry

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.

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)