Staging of Superficial EAC Using VLE
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
Site IRB
- Rochester, Minnesota: 17-002723
NCT ID: NCT03385343
Sponsor Protocol Number: 17-002723
About this study
This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.
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:
- Patient over the age of 18
- Patient undergoing an upper endoscopy with prior-biopsy confirmed Barrett's Esophagus.
- Ability to provide written, informed consent
- No significant esophagitis (LA grade
Exclusion Criteria:
- Patients who have achieved complete remission of intestinal metaplasia (CR-IM)
- Patients without visible Barrett's Esophagus at the time of study esophagogastroduodenoscopy (EGD)
- Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
- Prior esophageal or gastric surgical resection
- Significant esophageal stricture requiring dilatation
- Patients who require anticoagulation for who biopsy would be contraindicated
- Patients who are known to be pregnant
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Cadman Leggett, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available