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OpenTrials
Completed

NCT Number: NCT02031900

High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging System

This is a single center, single arm, open label observational trial of patients undergoing EGD. The primary objective of this clinical trial is to evaluate the ability of physicians to position the NvisionVLE Optical Probe to acquire an image of an area of the esophagus to identify and discriminate abnormal areas of tissue from normal.

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Key information

Conditions

Undergoing Esophagogastroduodenoscopy (EGD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and females over the age of 18 years.
  • Patients presenting for an EGD.
  • 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 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 NvisionVLE catheter.
  • Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE catheter.
  • Patients with known inflammatory disease, esophageal tears or ulcers, which prohibit full distention of the balloon from the NvisionVLE catheter.
  • Patients with known eosinophilic esophagitis.
  • Patients that 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 Willibrand's disease or other known platelet malfunction disorders.

Treatment and study plan

NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory Kit

Device

The NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization.

Primary outcomes

  1. The primary endpoint will be the number of patients achieving a VLE (volumetric laser endomicroscopy) image that includes stomach, gastro esophageal junction (GEJ) and esophagus.

    Time frame: 1 day

    Achieving a VLE image is defined as completing a full 6cm scan. This will be presented as a percentage of patients.

Secondary outcomes

  1. The evaluation of procedural workflow and physician interface to the NvisionVLE Imaging Console.

    Time frame: 1 day

    Procedural workflow and physician interface to the console will be assessed by a questionnaire that will be completed by the investigational staff involved in the procedure.

Sponsors and collaborators

Lead sponsor

NinePoint Medical

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2014
Registry last updated
Mar 26, 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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