Clinical trial NCT01503411: High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE)
Official title: High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus
Lead sponsor: NinePoint Medical
Sponsor class: INDUSTRY
First posted: 2012-01-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Massachusetts
city: Kansas City
country: United States
facility: VA Medical Center
state: Missouri
Study officials:
affiliation: Mayo Clinic
name: Herbert C. Wolfsen, MD
role: STUDY_CHAIR
affiliation: University Medical Center, Kansas City, MO
name: Prateek Sharma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic, Rochester, MN
name: Kenneth Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Herbert C Wolfsen, MD
role: PRINCIPAL_INVESTIGATOR
References: