Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System
Overview
Tab Title Description
Study type
InterventionalDescribes 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
NCT ID: NCT02864043
Sponsor Protocol Number: 16-01
About this study
The purpose of this study is to evaluate the performance of the NvisionVLE® Imaging System for determining features of dysplastic Barrett's Esophagus by collection and analysis of medical record information, imaging data, and pathology results. The study is for patients who have a prior biopsy-confirmed diagnosis of Barrett's esophagus with dysplasia and are scheduled to have an endoscopic evaluation.
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
- Over the age of 18
- Is undergoing an upper endoscopy for Barrett's Esophagus surveillance with prior biopsy-confirmed BE with dysplasia (at least LGD)
- Able to provide written, informed consent
- No significant esophagitis (LA grade < B, C and D)
Exclusion Criteria
- Has achieved complete remission of intestinal metaplasia (CR-IM)
- Is without visible BE at time of study EGD
- Use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU)
- Prior esophageal or gastric surgical resection
- Significant esophageal stricture requiring dilatation
- Requires anticoagulation (biopsy would be contraindicated)
- Known to be pregnant
More information
Publications
Publications are currently not available