Argyle Fistula Cannula Pre-market, Prospective, Single Arm, Non-randomized, Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Successful Hemodialysis Sessions
研究概览
简要总结
The purpose of the investigation is to confirm the safety and performance of the Argyle™ Safety Fistula Cannula with Anti-reflux Valve for hemodialysis treatment.
详细描述
The study will be performed at up to 5 US hemodialysis clinics.
Qualified patients who choose to participate and sign informed consent will be enrolled in the study. The investigational sites chosen to participate in this study will be trained on the insertion procedure using plastic fistula cannulas according to established curriculum. A combination of didactic training followed by insertion using a cannulation arm will be conducted. Cannulation on consented subjects will begin after the inserter demonstrates proficiency on the cannulation arm. Proficiency definitions are outlined in the protocol. After two supervised (by Medtronic and/or dedicated, trained super user) successful cannulations on consented subjects, the clinician will be permitted to cannulate without supervision.
Data supporting the primary, secondary, and exploratory objectives will be captured following thirty-six (36) hemodialysis sessions for each enrolled subject.
Cannulations will be performed by a minimum of five different clinicians at up to 5 dialysis clinic sites.
The investigational sites chosen to participate in this study will be trained on the insertion procedure using plastic fistula cannulas for a pre-determined period and according to established curriculum. A combination of didactic training followed by insertion using a cannulation arm will be conducted. After two supervised (by Medtronic and/or dedicated, trained super user) successful cannulations on consented subjects, the clinician will be permitted to cannulate without supervision and the data collection for the primary and secondary objectives will begin. Hemodialysis sessions will be performed, according to the investigator's prescription, throughout the duration of the study. Dialysis adequacy will be verified at baseline and during the mid-week session on weeks 1, 3, 6 and 12. Other than the blood sampling, there are no study-specific procedures, other than cannulation with the Argyle™ Safety Fistula Cannula with Anti-Reflux Valve, that will be required.
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 who is aged 18 years or older who signed informed consent
- •Subject is undergoing in-center hemodialysis
- •Subject has an arteriovenous fistulae (AVF) fistula that was determined to be mature by standard clinical definition
排除标准
- •Subject is enrolled in another study that could confound the results of this study, without documented pre-approval
- •Subject with an existing arteriovenous graft
- •Subjects with known allergies to plastics
- •Subjects who are unable to read or respond to the questionnaire about satisfaction
研究组 & 干预措施
Argyle Fistula Cannula Subjects
All subjects enrolled in the study and treated with the Argyle Safety Fistula Cannula with Anti-reflux Valve
干预措施: Argyle Safety Fistula Cannula with Anti-Reflux Valve (Device)
结局指标
主要结局
Successful Hemodialysis Sessions
时间窗: through study completion, an average of 1 year
The primary objective is the percentage of successful hemodialysis sessions using the Argyle™ Safety Fistula Cannula with Anti-reflux Valve.
次要结局
- Cannulator Satisfaction Questionnaire(through study completion, an average of 1 year)
- Subject Satisfaction Questionnaire(through study completion, an average of 1 year)
- Dialysis adequacy(through study completion, an average of 1 year)
- Successful Cannulations(through study completion, an average of 1 year)
- Access-related complications requiring procedural intervention(through study completion, an average of 1 year)
- Compare prescribed blood flow rates(through study completion, an average of 1 year)
- Impact of delay between training and use of device(through study completion, an average of 1 year)
- Cannulation Locations with securement details(through study completion, an average of 1 year)