Solv Multi-Pass Hemodialysis System In-Center Clinical Study

Обзор

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.

Вмешательства

• Устройство Solv Multi-Pass Hemodialysis System
  Solv Multi-Pass Hemodialysis System

Первичные конечные точки

• Primary Safety Endpoint [Срок оценки: through study completion, an average of 1 year]
• Primary Performance Endpoint [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (10)

• Serious adverse events and all device and/or therapy related adverse events [Срок оценки: through study completion, an average of 1 year]
• Uremic toxin profile [Срок оценки: through study completion, an average of 1 year]
• Electrolyte balance and evaluate mineral metabolism [Срок оценки: through study completion, an average of 1 year]
• Nutritional status [Срок оценки: through study completion, an average of 1 year]
• Inflammation markers [Срок оценки: through study completion, an average of 1 year]
• Volume of UF removed [Срок оценки: through study completion, an average of 1 year]
• Use of intradialytic medications [Срок оценки: through study completion, an average of 1 year]
• Patient-reported outcome measures with KDQOL-36 [Срок оценки: through study completion, an average of 1 year]
• Patient-reported outcome measures with Dialysis Recovery Time Questionnaire [Срок оценки: through study completion, an average of 1 year]
• User Experience with Solv [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Carolina Nephrology — Greenville

Идентификаторы

NCT: NCT07216885 · MDT22047

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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