NCT07216885 · Mozarc Medical US LLC
Solv Multi-Pass Hemodialysis System In-Center Clinical Study
What this study is about
Solv In-Center clinical study is a pre-market, forward-looking, conducted at multiple hospitals, single treatment group$1, where both patients and doctors know the treatment given clinical study. The patient population will include patients with kidney failure or insufficiency requiring hemodialysis and/or ultrafiltration.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Greenville, South Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2026 · Source of record for eligibility and locations