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

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ClinicalTrials.gov Identifier: NCT02864043
Recruitment Status : Active, not recruiting
First Posted : August 11, 2016
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
NinePoint Medical

Study Description
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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).

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Device: NvisionVLE with Real Time Targeting Procedure: esophagogastroduodenoscopy (EGD) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Identification of Features Associated With Dysplasia Using the NvisionVLE® Imaging System Pilot Trial
Actual Study Start Date : September 2016
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Performance of manually identified VLE features in predicting biopsy defined dysplasia [ Time Frame: Up to 2 years post data collection ]
    To determine the per-biopsy performance of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia


Secondary Outcome Measures :
  1. Per Patient Sensitivity and specificity for detecting dysplasia [ Time Frame: Up to 2 years post data collection ]
    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.

  2. Per Biopsy Sensitivity and specificity for detecting dysplasia [ Time Frame: Up to 2 years post data collection ]
    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.

  3. Per Biopsy performance of VLE compared to standard-of-care for detecting dysplasia [ Time Frame: Up to 2 years post data collection ]
    3. To compare, on a per-biopsy basis, the performance of VLE and standard-of-care to standard-of-care alone in detecting dysplasia.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864043


Locations
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United States, California
UC Irvine Medical Center
Irvine, California, United States, 92617
United States, Massachusetts
VA Boston
Boston, Massachusetts, United States, 02130
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
NinePoint Medical
Investigators
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Principal Investigator: Kenneth Wang, MD Mayo Clinic
More Information
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Responsible Party: NinePoint Medical
ClinicalTrials.gov Identifier: NCT02864043    
Other Study ID Numbers: 16-01
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by NinePoint Medical:
Barrett's Esophagus
Barrett's
OCT
VLE
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases