NCT02864043

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

3.8 years

First QC Date

August 2, 2016

Last Update Submit

March 3, 2020

Conditions

Barrett's Esophagus

Keywords

Barrett's EsophagusBarrett'sOCTVLE

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Per Patient Sensitivity and specificity for detecting dysplasia

    Up to 2 years post data collection

  • Per Biopsy Sensitivity and specificity for detecting dysplasia

    Up to 2 years post data collection

  • Per Biopsy performance of VLE compared to standard-of-care for detecting dysplasia

    Up to 2 years post data collection

Study Arms (1)

EGD with NvisionVLE with Real Time Targeting

OTHER

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 TargetingProcedure: esophagogastroduodenoscopy (EGD)

Interventions

NvisionVLE with Real Time TargetingDEVICE

Physician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe

EGD with NvisionVLE with Real Time Targeting
esophagogastroduodenoscopy (EGD)PROCEDURE

Standard of care EGD

EGD with NvisionVLE with Real Time Targeting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UC Irvine Medical Center

Irvine, California, 92617, United States

Location

VA Boston

Boston, Massachusetts, 02130, United States

Location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Kenneth Wang, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 11, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(5)