Probe-based Volumetric Laser Endomicroscopy (pVLE) of Endoscopic Mucosal Resection (EMR) Tissue in Patients With Barrett's Dysplasia
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
- Rochester, Minnesota: 12-006665
NCT ID: NCT02366039
Sponsor Protocol Number: 12-006665
About this study
This study is to assess the diagnostic accuracy and precision of the Probe-based Volumetric Laser Endomicroscopy (pVLE) imaging system in detecting dysplasia in BE in both in vivo and ex vivo imaging of Endoscopic Mucosal Resection (EMR) tissue, as compared to standard histopathology
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 over the age of 18 years.
- Patients with either suspected or confirmed Barrett's-associated high grade dysplasia (HGD) or intramucosal cancer (IMC) presenting for endoscopy possibly requiring EMR.
- Ability to provide written, informed consent.
- Females must be willing to take a pregnancy test if still capable of bearing a child.
Exclusion Criteria:
- Patients on anticoagulation undergoing high risk procedures in accordance to ASGE guideline for the management of antithrombotic agents for endoscopic procedures (2009)*.
- Patients with esophageal varices that preclude biopsies.
- Presence of an esophageal mass/cancer that precludes full distention of the balloon from the Nvision balloon guide sheath.
- Patients with esophageal strictures that would prevent adequate expansion of the balloon from the Nvision guide sheath.
- Patients with known inflammatory disease, esophageal tears or ulcers, which prohibit full distention of the balloon from the Nvision balloon guide sheath.
- Patients with known eosinophilic esophagitis.
- Patients who are pregnant.
- Patients with a history of hemostasis disorders.*
- Patients on anticoagulation undergoing low risk procedures are not excluded.
* Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (< 100,000 plt/ul) and individuals with von Willebrand's disease or other known platelet malfunction disorders.
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