A Registry of High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging System
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 14-004968
NCT ID: NCT02215291
Sponsor Protocol Number: 13_02
About this study
The purpose of this registry of patients undergoing EGD or endoscopy is to provide a collection of patient NvisionVLE™ (volumetric laser endomicroscopy) procedural data for participating physicians, including, but not limited to, imaging data, clinical utility data, demographics, pathology, treatment, and long term follow up.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Michael Wallace, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available