Bile Duct Diseases
Conditions
Brief summary
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
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.
Interventions
DEVICEERCP with NvisionVLE® Imaging Low Profile System
Endoscopic Retrograde Cholangio-Pancreatography (ERCP) with NvisionVLE® Imaging Low Profile System
Sponsors
Methodist Health System
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demographics- DOB | up to 2 years | Date of birth |
| Demographics- Sex | up to 2 years | Male/Female |
| Indication of Procedure | up to 2 years | Anatomy Used: Biliary or Pancreatic |
| Previous Surgical History | up to 2 years | Stent type and Location |
| Previous Imaging | up to 2 years | Type of Imaging: CT or MRI for example |
| Previous Procedures | up to 2 years | EUS or ERCP |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPrashant Kedia, MD
The Methodist Hospital Research Institute
Outcome results
None listed