Solv Multi-Pass Hemodialysis System In-Center Clinical Study

Medtronic

Status

Not yet enrolling

Conditions

End Stage Renal Disease

Treatments

Device: Solv Multi-Pass Hemodialysis System

Study type

Interventional

Funder types

Industry

Identifiers

NCT07216885

MDT22047

Details and patient eligibility

About

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.

Enrollment

46 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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