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临床试验/NCT05263752
NCT05263752已完成不适用

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

Methodist Health System1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
1
主要终点
Demographics- DOB

研究概览

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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