Back to search results

Solv Multi-Pass Hemodialysis System for End Stage Renal Disease

This study is testing a new device called the Solv Multi-Pass Hemodialysis System for people with End Stage Renal Disease (ESRD), also known as kidney failure. The goal is to see how safe and effective this new system is over about one year. You might be able to join if you are 18 or older and have ESRD, whether you're new to dialysis or already receiving it in a clinic. The study will look at how well the system works and if there are any side effects. There are no specific biomarkers (biological signs) being detected for eligibility.

Study design
This is a single-arm, open-label study, meaning all 46 participants will receive the Solv Multi-Pass Hemodialysis System, and both you and the study team will know what treatment you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and the device's performance will be measured through study completion, which is an average of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07216885

Solv Multi-Pass Hemodialysis System In-Center Clinical Study

Recruiting
NAAges 18+InterventionalTreatment
Mozarc Medical US LLC
~46 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Solv Multi-Pass Hemodialysis System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint
Measured over through study completion, an average of 1 year
+1 more outcome measured

Conditions

End Stage Renal Disease

Explore related trials

Chronic Kidney Disease, Stage 5

Where it's being run

1 sites across 1 states
South Carolina1

Who to contact

Sr. Clinical Research Director
[email protected]
877-211-1850
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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

What this trial measures

  • Primary Safety Endpointthrough 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 Endpointthrough 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.