Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System (DDP)

Identification of Features Associated With Dysplasia Using the NvisionVLE® Imaging System Pilot Trial

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).

Study Overview

• Status: Unknown
• Conditions: Barrett's Esophagus
• Intervention / Treatment: Device: NvisionVLE with Real Time Targeting; Procedure: esophagogastroduodenoscopy (EGD)

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92617
      • UC Irvine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • VA Boston
  • Minnesota
    • Rochester, Minnesota, United States, 55901
      • Mayo Clinic
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EGD with NvisionVLE with Real Time Targeting; Physician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe following standard of care endoscopy	Device: NvisionVLE with Real Time Targeting; Physician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe; Procedure: esophagogastroduodenoscopy (EGD); Standard of care EGD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of manually identified VLE features in predicting biopsy defined dysplasia	To determine the per-biopsy performance of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia	Up to 2 years post data collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Per Patient Sensitivity and specificity for detecting dysplasia	1. To determine the absolute per-patient sensitivity and specificity of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia.	Up to 2 years post data collection
Per Biopsy Sensitivity and specificity for detecting dysplasia	2. To determine the absolute per-biopsy sensitivity and specificity of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia.	Up to 2 years post data collection
Per Biopsy performance of VLE compared to standard-of-care for detecting dysplasia	3. To compare, on a per-biopsy basis, the performance of VLE and standard-of-care to standard-of-care alone in detecting dysplasia.	Up to 2 years post data collection

Collaborators and Investigators

• Sponsor: NinePoint Medical
• Investigators: Principal Investigator: Kenneth Wang, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: OCT; Barrett's Esophagus; Barrett's; VLE
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 16-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No