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

Completed

• Conditions: Barrett's Esophagus

• Registration Number: NCT01503411
• Lead Sponsor: NinePoint Medical

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-27
• Study First Submitted QC: 2011-12-30
• Study Start: 2012-01
• Study First Posted: 2012-01-04
• Primary Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	The research participants will be followed and evaluated for the duration of their VLE procedure, an expected average of 10 additional minutes beyond the standard EDG procedure.	The primary endpoint will be the number of subjects achieving completed VLE imaging studies at the time of EDG.

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Massachusetts, United States

VA Medical Center; 🇺🇸 Kansas City, Missouri, United States