High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE)

Completed

Conditions studied: Barrett's Esophagus

In brief

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 esophagogastroduodenoscopy (EGD) and to identify work-flow and training implications for introducing this new imaging modality.

Key facts

Study ID

NCT01503411

Run by

NinePoint Medical

People needed

120

Starts

2012-01-01

Last updated by the study team

2014-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States
• Mayo Clinic — Rochester, Massachusetts, United States
• VA Medical Center — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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