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

NCT01503411 | Completed

• 1 other identifier: Protocol No. 11_01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Barrett's Esophagus

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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) for suspected or confirmed Barrett's esophagus (BE)or for non-BE related conditions other than esophageal varices.

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• NinePoint Medical: lead

Study Sites (3)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Massachusetts, 55905, United States

Location

VA Medical Center

Kansas City, Missouri, 64128, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Herbert C. Wolfsen, MD

  Mayo Clinic

  STUDY CHAIR

• Prateek Sharma, MD

  University Medical Center, Kansas City, MO

  PRINCIPAL INVESTIGATOR

• Kenneth Wang, MD

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

• Herbert C Wolfsen, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 27, 2011
• First Posted: January 4, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

US (3)