Evaluation of Safety and Efficacy of NvisionVLE® Imaging Low Profile System in Patients With Bile Duct Disease

Study Overview
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Brief Summary
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A previous study evaluating the NvisionVLE® Imaging Low Profile System revealed the system to be feasible and safe for use in bile duct. The study also revealed a potential to better define abnormalities, target sampling and therapy when utilizing the NvisionVLE® Imaging Low Profile System. This study will further evaluate the safety and efficacy of the NvisionVLE® Imaging Low Profile System in patients with bile duct diseases.

Detailed Description
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The primary objective of this retrospective and prospective study is to acquire additional data to further evaluate the safety and efficacy of the NvisionVLE® Imaging Low Profile System in patients with bile duct disease. The secondary objective will be to provide a tool for participating physicians to collect imaging data, clinical utility data, and other clinical data such as demographics, pathology, and treatment surveillance results for patients who have undergone an examination of the bile duct with the NvisionVLE® Imaging Low Profile System. Specific aims include completing a multi-center registry to further evaluate the safety and efficacy of the NvisionVLE® Imaging System Low Profile System and developing a tool from the NvisionVLE® Imaging Low Profile System data to better define abnormalities, target sampling and therapy in patients with bile duct disease.

Official Title
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Evaluation of Safety and Efficacy of NvisionVLE® Imaging Low Profile System in Patients With Bile Duct Disease

Conditions
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Bile Duct Diseases

Intervention / Treatment
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* Device: ERCP with NvisionVLE® Imaging Low Profile System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Undergone ERCP with NvisionVLE® Imaging Low Profile System at MDMC between 10/15/2017 and 10/15/2019. Exclusion Criteria: Below 18 years of age Did not undergo ERCP with NvisionVLE® Imaging Low Profile System at MDMC

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Undergone ERCP with NvisionVLE® Imaging Low Profile System<br>Undergone ERCP with NvisionVLE® Imaging Low Profile System at MDMC between 10/15/2017 and 10/15/2019 | Device: ERCP with NvisionVLE® Imaging Low Profile System<br>* Endoscopic Retrograde Cholangio-Pancreatography (ERCP) with NvisionVLE® Imaging Low Profile System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics- DOB | Date of birth | up to 2 years | 
| Demographics- Sex | Male/Female | up to 2 years | 
| Indication of Procedure | Anatomy Used: Biliary or Pancreatic | up to 2 years | 
| Previous Surgical History | Stent type and Location | up to 2 years | 
| Previous Imaging | Type of Imaging: CT or MRI for example | up to 2 years | 
| Previous Procedures | EUS or ERCP | up to 2 years |