EUS Procedures Using RIVOS™ EUS Access Device
Registry of Patients Undergoing Endoscopic Ultrasound (EUS) Procedures Using the RIVOS™ EUS Access Device
研究概览
地位
详细说明
Endoscopic ultrasound (EUS)-guided interventions are becoming the first-line treatment of various pancreaticobiliary disorders such as malignant biliary obstruction, access to bile duct or pancreatic duct after failed ERCP, and drainage of pancreatic, peripancreatic or intraabdominal fluid collections. However, given the lack of dedicated devices for performing these complex interventions, accessories used to perform endoscopic retrograde cholangiopancreatography (ERCP) are currently being used off-label to perform most interventional EUS procedures.
The RIVOS™ EUS access device is a novel, FDA approved device that has been specifically developed for performing EUS-guided interventions. The device has a sharp trocar tip to allow access to the target organ, a flexible access cannula to allow contrast injection and passage of a guidewire, and an electrocautery-tip to facilitate the creation of a fistula. This innovative design is expected to simplify the technical aspects of the procedure and improve the safety profile for these complex endoscopic interventions.
The aim of this study is to evaluate the technical and treatment outcomes in patients undergoing standard of care, interventional EUS-guided procedures in patients with pancreaticobiliary disorders using the RIVOS™ EUS access device.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Ji Young Bang, MD MPH
- 电话号码：321-842-2273
- 邮箱：jiyoung.bang@orlandohealth.com
研究联系人备份
- 姓名：Barbara J Broome
- 电话号码：321-841-3742
- 邮箱：barbara.broome@orlandohealth.com
学习地点
-
-
Florida
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Orlando、Florida、美国、32806
- 招聘中
- Orlando Health Digestive Health Institute
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首席研究员：
- Ji Young Bang, MD MPH
-
接触：
- Ji Young Bang, MD MPH
- 电话号码：321-842-2273
- 邮箱：jiyoung.bang@orlandohealth.com
-
接触：
- Barbara J Broome
- 邮箱：barbara.broome@orlandohealth.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Age ≥ 18 years
- All patients undergoing EUS-guided interventions using the RIVOS™ EUS access device
Exclusion Criteria:
- Age < 18 years
- Patients who did not undergo EUS-guided interventions using the RIVOS™ EUS access device
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients requiring interventional EUS procedures
|
EUS-guided intervention using the RIVOS™ EUS access device
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Technical success
大体时间：1 day
|
Rate of technical success in patients undergoing EUS-guided procedures
|
1 day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment success
大体时间：4 weeks
|
Rate of treatment success, defined as the resolution of symptoms and/or radiological findings from underlying disease at 4-weeks following index intervention.
|
4 weeks
|
|
Adverse events
大体时间：4 weeks
|
Rate of adverse events, procedure-related and disease-related, in patients undergoing endoscopic ultrasound procedures.
|
4 weeks
|
|
Procedure duration
大体时间：1 day
|
Total procedure duration, defined as time taken from start of the EUS-procedure to time the echoendoscope is withdrawn from the patient.
|
1 day
|
|
Hospital admission
大体时间：4 weeks
|
Rate of hospital admission due to disease-related symptoms or procedure-related adverse events.
|
4 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2457590
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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