NCT07216885暂停不适用
Solv Multi-Pass Hemodialysis System In-Center Clinical Study
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
Solv In-Center clinical study is a pre-market, prospective, multicenter, single arm, open-label clinical study. The patient population will include patients with kidney failure or insufficiency requiring hemodialysis and/or ultrafiltration. Eligibility will be open to incident dialysis patients and patients currently receiving HD in an in-center environment. All vascular access types including AV-fistula, AV-graft, and tunneled hemodialysis catheters.
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
- •Subjects able and willing to give Informed Consent and interested to participate in the study
- •Subject aged 18 years or older
- •Subjects meets one of the following three conditions:
- •End stage renal disease (ESRD) patients who have been adequately treated with maintenance HD and deemed stable, according to the investigator, for at least three months
- •Incident end stage renal disease (ESRD) patients who have been prescribed HD therapy
- •Subjects on peritoneal dialysis who require conversion to hemodialysis, according to the investigator
- •Subjects who have adequate access, capable of providing a blood flow rate of at least 300 mL/min
- •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
排除标准
- •Subjects with baseline dry weight of ≤ 60 kg or ≥ 110 kg
- •Subjects with a documented history of non-compliance to scheduled hemodialysis sessions or clinic visits
- •Subjects who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to peritoneal dialysis (PD) within the next two months or who require single needle dialysis therapy
- •Subjects with unstable electrolytes or acid base balance, in the opinion of the investigator
- •Subjects with any major surgery or major adverse cardiac event within 3 months of screening
- •Subjects with hemodynamic instability, defined as repeated hypo/hypertension, in the past 30 days from screening
- •Subjects with active or ongoing infection, in the opinion of the Investigator
- •Subjects with known Hepatitis B, C or HIV infection
- •Subject with documented coagulation disorders, active or bleeding risk or who is intolerant to heparin
- •Subjects who are currently participating or have previously participated in another interventional clinical trial in the past 4 weeks from screening
- •Subjects with any comorbidities possibly conflicting with the study purpose or procedures, in the opinion of the Investigator
- •Subjects who are pregnant or lactating or any patient with a childbearing potential who refuses to use medically acceptable means of contraception
- •Subjects with an active, malignant disease and whose life expectancy is < 6 months, in the opinion of the investigator
- •Subjects with a hemoglobin < 9 gm/dl in the past 30 days from screening
- •Subjects with significant intradialytic hypotension in 30 days from screening
- •Subjects with shock within 30 days from screening
- •Subjects with active seizures in the last 6 months from screening
- •Subjects with history of hemolytic anemia or thrombocytopenia
- •Subjects with vascular access dysfunction (switching ports (reverse lines or catheter replacement) in 30 days prior to screening, multiple tPA (tissue plasminogen activator) administrations) or patient who has had a thrombectomy procedure within 30 days prior to screening
- •Subjects with a documented history of congestive heart failure with symptoms consistent with NYHA Class III or IV, according to the investigator, or documented severe left ventricular dysfunction
- •Subjects with fluid overload due to intractable ascites secondary to liver cirrhosis
- •Subjects with active, life-threatening rheumatologic disease
研究组 & 干预措施
Solv Multi-Pass Hemodialysis System In-Center Subjects
Experimental
All subjects enrolled in the study and treated with the Solv Multi-Pass Hemodialysis System
干预措施: Solv Multi-Pass Hemodialysis System (Device)
结局指标
主要结局
Primary Safety Endpoint
时间窗: through study completion, an average of 1 year
Evaluate the number of serious device-related adverse events that occur during the In-Center Phase of the study, to confirm there are no additional risks associated with the Solv System implementation of sorbent-based HD.
Primary Performance Endpoint
时间窗: through study completion, an average of 1 year
Evaluate the mean single pool (sp)Kt/V for subjects undergoing conventional In-Center HD with the Solv Multi-Pass Hemodialysis System during the eight-week study Phase.
次要结局
- Uremic toxin profile(through study completion, an average of 1 year)
- Electrolyte balance and evaluate mineral metabolism(through study completion, an average of 1 year)
- Serious adverse events and all device and/or therapy related adverse events(through study completion, an average of 1 year)
- Nutritional status(through study completion, an average of 1 year)
- Inflammation markers(through study completion, an average of 1 year)
- Volume of UF removed(through study completion, an average of 1 year)
- Use of intradialytic medications(through study completion, an average of 1 year)
- Patient-reported outcome measures with KDQOL-36(through study completion, an average of 1 year)
- Patient-reported outcome measures with Dialysis Recovery Time Questionnaire(through study completion, an average of 1 year)
- User Experience with Solv(through study completion, an average of 1 year)
研究者
研究点 (2)
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