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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Undergone ERCP with NvisionVLE® Imaging Low Profile System | Undergone ERCP with NvisionVLE® Imaging Low Profile System at MDMC between 10/15/2017 and 10/15/2019 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERCP with NvisionVLE® Imaging Low Profile System | Device | Endoscopic Retrograde Cholangio-Pancreatography (ERCP) with NvisionVLE® Imaging Low Profile System |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of patients over the age of 18 years who are scheduled to undergo an ERCP with Nvision VLE Imaging Low Profile System.
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| Name | Affiliation | Role |
|---|---|---|
| Prashant Kedia, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Health System | Dallas | Texas | 75203 | United States |
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| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |