High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE)

Barrett's Esophagus Clinical Trial

Official title:

High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503411
• Other study ID #: Protocol No. 11_01
• Status: Completed
• Phase: N/A
• First received: December 27, 2011
• Last updated: April 8, 2014
• Start date: January 2012

Study information

• Verified date: April 2014
• Source: NinePoint Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The primary objective of this clinical trial is to evaluate the performance of the Nvision Volumetric Laser Endomicroscopy (VLE) system to visualize subsurface tissue in subjects undergoing esophagogastroduodenoscopy (EGD) and to identify work-flow and training implications for introducing this new imaging modality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females over the age of 18 years.

• Patients with either suspected BE presenting for endoscopy or patients with documented BE presenting for follow-up endoscopy likely to require a biopsy or patients presenting for endoscopy for non-BE related conditions other than esophageal varices.

• 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 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 Nvision balloon guide sheath.

• Patients with esophageal strictures that would prevent adequate expansion of the balloon from the Nvision balloon guide sheath.

• Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the Nvision balloon guide sheath.

• Patients with known eosinophilic esophagitis.

• Patients that are pregnant.

• Patients with a history of hemostasis disorders.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	VA Medical Center	Kansas City	Missouri
United States	Mayo Clinic	Rochester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
NinePoint Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint	The primary endpoint will be the number of subjects achieving completed VLE imaging studies at the time of EDG.	The research participants will be followed and evaluated for the duration of their VLE procedure, an expected average of 10 additional minutes beyond the standard EDG procedure.	No