A Study to Evaluate the Feasibility of NvisionVLE® Imaging System Capsule Probe
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
- Scottsdale/Phoenix, Arizona: 19-008351
Sponsor Protocol Number: 19-008351
About this study
The purpose of this study is to determine the feasibility and tolerability of obtaining esophageal VLE images using the NvisionVLE® Imaging System Capsule Probe.
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:
- Males and females.
- 18 years of age or older.
- Treatment naive patient who is under BE surveillance or is presenting for dysplasia confirmation or initial treatment.
- Patient is able and willing to provide written informed consent.
- Patient has fasted per institutional guidelines.
Exclusion Criteria:
- Significant esophageal fistula or stricture requiring dilation.
- Symptoms of dysphagia.
- Suspicion or known history of gastrointestinal obstruction or mass, varices, rings or webs.
- Known tortuous esophageal/GEJ anatomy.
- Any prior esophageal treatment (e.g., ablation, dilation, surgery, etc.).
- Known inability to swallow pills and capsules, or history of a swallowing disorder (e.g., odynophagia, scleroderma, achalasia, esophageal stricture, or esophageal diverticulum.
- Current diagnosis of cancer.
- Patients for whom use of the Nvision VLE device would be in conflict with the Instructions for Use (IFU).
- Other major medical illnesses (e.g., unstable cardiovascular disease, end-stage liver or kidney disease, recent or suspected active GI bleeding).
- Patients who require anticoagulants.
- Patients who are known to be pregnant.
- Patients who are enrolled in a competing clinincal study.
- Patients for whom the physician feels would not be a good candidate to participate (physician discretion).
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 |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Francisco Ramirez, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available