Clinical trial NCT01844921: High Resolution Optical Imaging of the Esophagus Using the Nvision Volumetric Laser Endomicroscopy (VLE™) Imaging System
Official title: High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undergoing Esophagogastroduodenoscopy (EGD)
Lead sponsor: NinePoint Medical
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females \>18 years of age undergoing esophagogastroduodenoscopy (EGD).

Brief summary: 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 catheter to acquire an image of an area of the esophagus to identify and discriminate abnormal areas of tissue from normal.


Eligibility criteria: 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, and 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 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 would 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.

Primary outcomes:
measure: 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.
timeFrame: Day of procedure
Secondary outcomes:
measure: The evaluation of procedural workflow and physician interface to the NvisionVLE Imaging Console.
timeFrame: Day of procedure.
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: John Poneros, MD
role: PRINCIPAL_INVESTIGATOR
References: