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OpenTrials
Completed

NCT Number: NCT02366039

Probe-based Volumetric Laser Endomicroscopy (pVLE) of Endoscopic Mucosal Resection (EMR) Tissue in Patients With Barrett's Dysplasia

This study is to assess the diagnostic accuracy and precision of the Probe-based Volumetric Laser Endomicroscopy (pVLE) imaging system in detecting dysplasia in BE in both in vivo and ex vivo imaging of Endoscopic Mucosal Resection (EMR) tissue, as compared to standard histopathology

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

About this study

To assess the ability of pVLE to visualize subsurface architecture of EMR tissue, as compared to histology in both in vivo and ex vivo imaging.

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 or confirmed Barrett's-associated high grade dysplasia (HGD) or intramucosal cancer (IMC) presenting for endoscopy possibly requiring EMR.
  • Ability to provide written, informed consent.
  • Females must be willing to take a pregnancy test if still capable of bearing a child.

Exclusion criteria

  • Patients on anticoagulation undergoing high risk procedures in accordance to ASGE guideline for the management of antithrombotic agents for endoscopic procedures (2009)*.
  • Patients with esophageal varices that preclude biopsies.
  • Presence of an esophageal mass/cancer 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 guide sheath.
  • Patients with known inflammatory disease, esophageal tears or ulcers, which prohibit full distention of the balloon from the Nvision balloon guide sheath.
  • Patients with known eosinophilic esophagitis.
  • Patients who are pregnant.
  • Patients with a history of hemostasis disorders*.
  • Patients on anticoagulation undergoing low risk procedures are not excluded. ** Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (<100,000 plt/ul) and individuals with von Willebrand's disease or other known platelet malfunction disorders.

Treatment and study plan

Primary outcomes

  1. distinguishing between normal esophageal squamous mucosa and Barrett's dysplasia

    Time frame: at time of endoscopic mucosal resection

    We will assess descriptive and diagnostic performance (accuracy, sensitivity, specificity, positive and negative predictive values) of the Nvision pVLE device in visualizing dysplasia as compared to standard histopathology

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Fred Hutchinson Cancer Center

Registry information

Acronym: VLE EMR

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Feb 19, 2015
Registry last updated
Sep 13, 2023

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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