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OpenTrials
Completed

NCT Number: NCT01503411

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

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.

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Jacksonville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

NinePoint Medical

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
First posted
Jan 4, 2012
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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