Clinical trial NCT02864043: Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System
Official title: Identification of Features Associated With Dysplasia Using the NvisionVLE® Imaging System Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Barrett's Esophagus
Keywords: Barrett's Esophagus
Barrett's
OCT
VLE
Lead sponsor: NinePoint Medical
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The NvisionVLE® Dysplasia Detection Pilot Study is a prospective, non-randomized trial for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).

Detailed description: The NvisionVLE® Dysplasia Detection Pilot Study is a collection of data for research. Participation is completely voluntary and does not affect the patient's medical care that chooses not to participate. The purpose of this Study is to determine the performance of the NvisionVLE® Imaging System in determining features of dysplastic Barrett's Esophagus (BE). This is done by the collection and analysis of the medical record information, imaging data, and pathology results. The information is then stored and may be used at a later time for various future analyses and publications. Any future analyses involving this Study will only use the information collected in this Study. No further involvement or additional informed consent of participants will be needed if future analyses are performed.

This Study is designed for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).

The NvisionVLE® Imaging System is cleared for use by the U.S. Food and Drug Administration (FDA).

Patients who undergo an endoscopic evaluation of the esophagus with the NvisionVLE® Imaging System at participating hospitals will be invited to participate in this Study. The Study is taking place at up to 4 hospitals, and as many as 100 patients may participate in this Study.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18.
* Patients undergoing an upper endoscopy for BE surveillance with prior biopsy-confirmed BE with dysplasia (at least LGD).
* Ability to provide written, informed consent.
* No significant esophagitis (LA grade \< B, C and D).

Exclusion Criteria:

* Patients who have achieved complete remission of intestinal metaplasia (CR-IM)
* Patients without visible BE at time of study EGD.
* Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU).
* Prior esophageal or gastric surgical resection.
* Significant esophageal stricture requiring dilatation.
* Patients who require anticoagulation for whom biopsy would be contraindicated.
* Patients who are known to be pregnant.

Primary outcomes:
measure: Performance of manually identified VLE features in predicting biopsy defined dysplasia
timeFrame: Up to 2 years post data collection
Secondary outcomes:
measure: Per Patient Sensitivity and specificity for detecting dysplasia
timeFrame: Up to 2 years post data collection
measure: Per Biopsy Sensitivity and specificity for detecting dysplasia
timeFrame: Up to 2 years post data collection
measure: Per Biopsy performance of VLE compared to standard-of-care for detecting dysplasia
timeFrame: Up to 2 years post data collection
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UC Irvine Medical Center
state: California
city: Boston
country: United States
facility: VA Boston
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Mayo Clinic
name: Kenneth Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: