Solv Multi-Pass Hemodialysis System for In-Center Dialysis
Solv Multi-Pass Hemodialysis System In-Center Clinical Study
This study will test the Solv Multi-Pass Hemodialysis System during in-center dialysis for adults with end-stage kidney failure who need regular hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mozarc Medical US LLC Industry-sponsored |
| Locations | 1 site (Greenville, South Carolina) |
| Trial ID | NCT07216885 on ClinicalTrials.gov |
What this trial studies
This is a pre-market, prospective, multicenter, single-arm, open-label study testing the Solv Multi-Pass Hemodialysis System during routine in-center hemodialysis sessions. The study will enroll adults (18+) with end-stage renal disease, including both patients already on maintenance hemodialysis and incident patients newly prescribed HD, as well as patients converting from peritoneal dialysis. All vascular access types (AV fistula, AV graft, tunneled catheter) are allowed provided the access can support a blood flow of at least 300 mL/min. Detailed outcome measures and exclusion criteria are defined in the protocol and monitored during scheduled in-center treatments.
Who should consider this trial
Good fit: Ideal candidates are adults with end-stage renal disease who receive or are prescribed in-center hemodialysis and have vascular access able to provide at least 300 mL/min blood flow.
Not a fit: Patients under 18, those without adequate vascular access or who meet protocol exclusion criteria such as extreme low or high body weight may not benefit from participating.
Why it matters
Potential benefit: If successful, the device could offer an alternative in-center dialysis option that may improve treatment efficiency or clinical workflow for some patients.
How similar studies have performed: Related device trials in dialysis have shown mixed results, and this specific multi-pass system is a novel, pre-market approach that remains to be proven in clinical use.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Greenville, South Carolina
- Carolina Nephrology — Greenville, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Sr. Clinical Research Director
- Email: mike.serle@mozarcmedical.com
- Phone: 877-211-1850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.