A Prospective International Multicenter, Non-Interventional, Single Arm, Blinded Feasibility Study to Assess the Contactless Optical Monitoring of AV Access Using the PatenSee System in Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Comparison of "Look" assessment with PatenSee's relevant output
研究概览
简要总结
This is a prospective, non-interventional, single arm, international multicenter study in which up to 120 adult participants with kidney failure requiring regular hemodialysis through arteriovenous (AV) access (AV fistula or graft) will be recruited and evaluated using the PatenSee system.
Data captured on the PatenSee system will be analyzed and evaluated against standard of care clinical monitoring of AV accesses.
详细描述
For eligible participants, a clinical exam of the AV access ("Look, Listen, Feel") per SOC will be done by a qualified site clinician/nurse, followed by an assessment of the AV access using the PatenSee system on a weekly basis for 6 weeks, and then biweekly up to 1 year from enrollment. Additional data regarding imaging and complications of the AV access will be collected. Clinical decisions, such as referrals for further investigation and management of the AV access will be based solely on standard clinical monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Male and female adult patient aged ≥18 years old
- •Patient has a non-reversible kidney failure that requires long-term hemodialysis
- •Patient has a functioning AV access (AVF/G) in the upper extremity
- •Patient is able and willing to provide consent by signing an EC/IRB approved informed consent form
- •Patient is willing and able to follow the requirements of the study
排除标准
- •An active AV access infection
- •An AV access condition that will likely require revision, e.g., symptomatic steal syndrome
- •Expected to recover kidney function, receive a kidney transplant, transfer to peritoneal dialysis (PD) or transfer to non-study site during the study period.
- •Any reason per investigator's discretion for which the patient is not suitable for the study
- •Any medical or psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to adhere to study requirements
- •Previous participation in an interventional study within 30 days prior to study enrollment that may interfere with evaluation of the study endpoints
- •Female patient is pregnant or breastfeeding
结局指标
主要结局
Comparison of "Look" assessment with PatenSee's relevant output
时间窗: 6 weeks per patient
Agreement between the ability to detect AV access structure parameters by PatenSee's images and the ability to detect the same parameters by clinical monitoring
Comparison of "Listen & Feel" assessments with PatenSee's relevant output
时间窗: 6 weeks per patient
Agreement between the PatenSee audio analysis of the AV access bruit and the sound recording of the AV access using a standard digital stethoscope measured
次要结局
- Functionality endpoint - Average time to conduct PatenSee scanning data capture(Up to 12 months)
- Functionality endpoint - Proportion (%) of participants on whom the PatenSee was used as planned(Up to 12 months)
- Functionality endpoint - Average number of weeks participants obtained PatenSee measurements(Up to 12 months)