Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System (DDP)
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ClinicalTrials.gov Identifier: NCT02864043 |
Recruitment Status : Unknown
Verified March 2020 by NinePoint Medical.
Recruitment status was: Active, not recruiting
First Posted : August 11, 2016
Last Update Posted : March 4, 2020
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Condition or disease | Intervention/treatment | Phase |
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Barrett's Esophagus | Device: NvisionVLE with Real Time Targeting Procedure: esophagogastroduodenoscopy (EGD) | Not Applicable |
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 (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 |
Arm | Intervention/treatment |
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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
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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 |
- 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
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Principal Investigator: | Kenneth Wang, MD | Mayo Clinic |
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 |
Barrett's Esophagus Barrett's OCT VLE |
Barrett Esophagus Precancerous Conditions Neoplasms |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |