NCT06086470Unknown不适用
A Prospective Single-Center, Open Label, Non-Randomized Study Evaluating the Use of the Qidni/D Hemodialysis System by Subjects With End-Stage Renal Disease
Qidni Labs Inc.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events associated with the use of the Qidni/D device
研究概览
简要总结
The main goal of this clinical study is to evaluate the safety of the Qidni/D Hemodialysis System in patients with end-stage renal disease. The main question it aims to answer is:
Is the Qidni/D safe for performing hemodialysis?
Participants will be subjected to one treatment of hemodialysis for up to 4 hours with the use of the Qidni/D.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent.
- •Subject is at least 18 years and less than 75 years of age.
- •Subject has end-stage renal disease adequately treated by maintenance dialysis and has been deemed stable for at least three months by his/her treating nephrologist.
- •Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min for conventional treatment or 200-250 mL/min for nocturnal hemodialysis treatment.
- •Subject understands the nature of the procedures and the requirements of the study protocol.
- •Subject is willing and able to comply with the protocol requirements and return to the treatment center for all required treatments and clinical evaluations.
- •Subject has no childbearing potential or the Subject affirms they are not pregnant. Subject affirms using contraception measures to prevent potential pregnancies during the study period.
排除标准
- •Subject is unable to read English.
- •Subject has dementia or lacks capacity for self-care.
- •Life expectancy less than 12 months from first study procedure.
- •Subject unable to understand or cooperate with the hemodialysis nurse and dialysis care team.
- •Subject has a documented history of non-adherence to dialysis therapy that would prevent successful completion of the study.
- •Subject has had a recent major cardiovascular adverse event within the last 3 months.
- •Subject has a persistent pre-dialysis sitting systolic blood pressure less than 100 mmHg despite medical therapy.
- •Subject has ongoing, symptomatic intra-dialytic hypotension requiring medical intervention.
- •Subject has an active infection requiring antibiotics within the last 7 days.
- •Subject with fluid overload due to intractable ascites secondary to liver cirrhosis.
- •Subject is seroreactive for Hepatitis B Surface Antigen.
- •Subject has a history of adverse reactions to dialyzer membrane material.
- •Subject is participating in another investigative drug or device clinical study related to dialysis which conflicts with the execution of this study.
- •Subject is scheduled to receive an organ transplant during the course of the study: paired exchange or living donor.
- •Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.
- •Any other documented condition that the Investigator feels would prevent the Subject from successful inclusion in the study.
- •Subject has an active viral infection (eg. COVID-19).
- •Subject is on peritoneal dialysis.
结局指标
主要结局
Incidence and severity of adverse events associated with the use of the Qidni/D device
时间窗: 3 days
Adverse events will be recorded and adjudicated independently as to the severity and likelihood of association with treatment with the Qidni/D device.
次要结局
- Hemodynamic stability(1 day)
- Technical performance of the Qidni/D device(1 day)
- Efficacy of dialysis(1 day)
研究者
研究点 (1)
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