NCT04628949已完成不适用
A Single-Use Duodenoscope in a Real-World Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ambu A/S
- 入组人数
- 248
- 试验地点
- 18
- 主要终点
- To evaluate the ERCP procedural success rates with the aScope™ Duodeno endoscope when completing the ERCP procedure for the intended indication(s).
研究概览
简要总结
This study will assess how the aScope™ Duodeno endoscope performs in procedures that treat problems of the bile and pancreatic ducts.
详细描述
This is a prospective, non-randomized, single-arm post-market observational clinical study that will assess the single-use Ambu® aScope™ Duodeno for non-emergent, standard of care (SOC) ERCP procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 years old.
- •Subject is indicated and scheduled for an elective, non-emergent ERCP.
- •Subject is willing and able to give informed consent and HIPAA authorization.
排除标准
- •Subject has altered pancreaticobiliary anatomy including:
- •Billroth II
- •Roux-en-Y gastric bypass
- •Loop gastric bypass
- •Post-Whipple
- •Roux-en-Y hepaticojejunostomy
- •Subject requires an emergency ERCP (emergent decompression procedure within 6-12 hours of presentation to prevent life-threatening sequelae).
- •Subject has any of the following severe co-morbid conditions
- •Morbid obesity (BMI ≥ 40)
- •Unstable cardiopulmonary conditions
- •Severe and uncorrectable coagulopathy
- •Severe and uncorrectable thrombocytopenia
- •Subject has clinically significant esophageal, pyloric or duodenal strictures.
- •Subject has been previously been treated under this investigational plan.
- •Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
- •Subject is actively taking an anticoagulant or antiplatelet agent other than aspirin.
- •Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not allow the subject to be a good study candidate.
结局指标
主要结局
To evaluate the ERCP procedural success rates with the aScope™ Duodeno endoscope when completing the ERCP procedure for the intended indication(s).
时间窗: Procedure Completion (Day 0)
Procedure success will be defined as the successful completion of the ERCP procedure with the aScope™ Duodeno endoscope. The procedural success rate will be the incidence rate of success for the ERCP procedure.
次要结局
- To evaluate the device deficiency rate for the aScope™ Duodeno endoscope.(Procedure Completion (Day 0))
- To evaluate physician satisfaction with the aScope™ Duodeno endoscope.(Procedure Completion (Day 0))
- To evaluate rate of conversion to a reusable endoscope, other endoscope or an open procedure from the aScope™ Duodeno endoscope during the ERCP procedure.(Procedure Completion (Day 0))
- To establish comprehensive performance attributes of aScope™ Duodeno endoscope through its use by multiple endoscopists in conducting various ERCP procedures.(Procedure Completion (Day 0))
- To evaluate rate of successful completion of a converted ERCP procedure.(Procedure Completion (Day 0))
研究者
研究点 (18)
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