Status:
NOT_YET_RECRUITING
Solv Multi-Pass Hemodialysis System In-Center Clinical Study
Lead Sponsor:
Medtronic - MITG
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 requir...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT07216885
Start Date
December 1 2025
End Date
July 1 2026
Last Update
October 15 2025
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