Evaluation of Safety and Efficacy of NvisionVLE® Imaging Low Profile System in Patients With Bile Duct Disease
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Bile Duct Diseases
- 发起方
- Methodist Health System
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Demographics- DOB
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •Age 18 years or older
- •Undergone ERCP with NvisionVLE® Imaging Low Profile System at MDMC between 10/15/2017 and 10/15/2019.
排除标准
- •Below 18 years of age
- •Did not undergo ERCP with NvisionVLE® Imaging Low Profile System at MDMC
结局指标
主要结局
Demographics- DOB
时间窗: up to 2 years
Date of birth
Previous Surgical History
时间窗: up to 2 years
Stent type and Location
Previous Imaging
时间窗: up to 2 years
Type of Imaging: CT or MRI for example
Demographics- Sex
时间窗: up to 2 years
Male/Female
Indication of Procedure
时间窗: up to 2 years
Anatomy Used: Biliary or Pancreatic
Previous Procedures
时间窗: up to 2 years
EUS or ERCP