Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System (DDP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02864043|
Recruitment Status : Active, not recruiting
First Posted : August 11, 2016
Last Update Posted : March 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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|
|Boston, Massachusetts, United States, 02130|
|United States, Minnesota|
|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|