Status:
COMPLETED
High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE)
Lead Sponsor:
NinePoint Medical
Conditions:
Barrett's Esophagus
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this clinical trial is to evaluate the performance of the Nvision Volumetric Laser Endomicroscopy (VLE) system to visualize subsurface tissue in subjects undergoing esophagoga...
Eligibility Criteria
Inclusion
- Males and females over the age of 18 years.
- Patients with either suspected BE presenting for endoscopy or patients with documented BE presenting for follow-up endoscopy likely to require a biopsy or patients presenting for endoscopy for non-BE related conditions other than esophageal varices.
- Ability to provide written, informed consent.
- Females who are able to become pregnant, 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 Nvision balloon guide sheath.
- Patients with esophageal strictures that would prevent adequate expansion of the balloon from the Nvision balloon guide sheath.
- Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the Nvision balloon guide sheath.
- Patients with known eosinophilic esophagitis.
- Patients that are pregnant.
- Patients with a history of hemostasis disorders.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01503411
Start Date
January 1 2012
Last Update
April 9 2014
Active Locations (3)
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1
Mayo Clinic
Jacksonville, Florida, United States, 32224
2
Mayo Clinic
Rochester, Massachusetts, United States, 55905
3
VA Medical Center
Kansas City, Missouri, United States, 64128