High Resolution Optical Imaging of the Esophagus Using the Nvision Volumetric Laser Endomicroscopy (VLE™) Imaging System

NCT01844921 | Completed

• 1 other identifier: 12_02
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Undergoing Esophagogastroduodenoscopy (EGD)

Outcome Measures

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.

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

  Day of procedure

Secondary Outcomes (1)

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

  Day of procedure.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and females \>18 years of age undergoing esophagogastroduodenoscopy (EGD).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NinePoint Medical: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Study Officials

• John Poneros, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

US (1)