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

April 8, 2014 updated by: NinePoint Medical
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Massachusetts
      • Rochester, Massachusetts, United States, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Males and females >18 years of age undergoing esophagogastroduodenoscopy (EGD) for suspected or confirmed Barrett's esophagus (BE)or for non-BE related conditions other than esophageal varices.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NinePoint Medical

Investigators

  • Study Chair: Herbert C. Wolfsen, MD, Mayo Clinic
  • Principal Investigator: Prateek Sharma, MD, University Medical Center, Kansas City, MO
  • Principal Investigator: Kenneth Wang, MD, Mayo Clinic, Rochester, MN
  • Principal Investigator: Herbert C Wolfsen, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

December 27, 2011

First Submitted That Met QC Criteria

December 30, 2011

First Posted (Estimate)

January 4, 2012

Study Record Updates

Last Update Posted (Estimate)

April 9, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol No. 11_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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