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

NCT02031900 | Completed

• 1 other identifier: 13-01
• 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 Optical Probe 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.

  1 day

Secondary Outcomes (1)

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

  1 day

Study Arms (1)

Undergoing EGD

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

Interventions

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.

Undergoing EGD

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, are willing to take a pregnancy test.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NinePoint Medical: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Prashanthi Thota, MD

  The Cleveland Clinic

  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: January 7, 2014
• First Posted: January 9, 2014
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

US (1)