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

Barrett's Esophagus Clinical Trial

— DDP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02864043
• Other study ID #: 16-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 1, 2020

Study information

• Verified date: March 2020
• Source: NinePoint Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

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

Locations

Country	Name	City	State
United States	VA Boston	Boston	Massachusetts
United States	UC Irvine Medical Center	Irvine	California
United States	North Shore University Hospital	Manhasset	New York
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
NinePoint Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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