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.

Study Overview

• Status: Completed
• Conditions: Undergoing Esophagogastroduodenoscopy (EGD)
• Intervention / Treatment: Device: NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory Kit

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Undergoing EGD	Device: NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory Kit; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The evaluation of procedural workflow and physician interface to the NvisionVLE Imaging Console.	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.	1 day

Collaborators and Investigators

• Sponsor: NinePoint Medical
• Investigators: Principal Investigator: Prashanthi Thota, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 21, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 13-01