Status:
COMPLETED
High Resolution Optical Imaging of the Esophagus Using the Nvision Volumetric Laser Endomicroscopy (VLE™) Imaging System
Lead Sponsor:
NinePoint Medical
Conditions:
Undergoing Esophagogastroduodenoscopy (EGD)
Eligibility:
All Genders
18+ years
Brief Summary
This is a single center, single arm, open label observational trial of patients undergoing EGD. The primary objective of this clinical trial is to evaluate the ability of physicians to position the Nv...
Eligibility Criteria
Inclusion
- Males and females over the age of 18 years.
- Patients presenting for an EGD.
- Ability to provide written, informed consent.
- Females who are able to become pregnant, and are willing to take a pregnancy test.
Exclusion
- Patients on anticoagulation undergoing high risk procedures in accordance to American Society For Gastrointestinal Endoscopy (ASGE) guideline for the management of antithrombotic agents for endoscopic procedures (2009)\*.
- Patients with esophageal varices that preclude biopsies.
- Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Catheter.
- Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Catheter.
- Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Catheter.
- Patients with known eosinophilic esophagitis.
- Patients that 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 Willibrand's disease or other known platelet malfunction disorders.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01844921
Start Date
April 1 2013
End Date
May 1 2013
Last Update
May 17 2013
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032