RecruitingNot ApplicableNCT07216885

Solv Multi-Pass Hemodialysis System In-Center Clinical Study


Sponsor

Mozarc Medical US LLC

Enrollment

46 participants

Start Date

Jan 13, 2026

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of dialysis machine called the Solv Multi-Pass Hemodialysis System, which cleans the blood of people whose kidneys no longer work. Researchers want to see if this system is safe and effective compared to standard dialysis. **You may be eligible if...** - You are 18 or older and have kidney failure (end-stage renal disease) - You are already on hemodialysis and have been stable for at least 3 months, OR you are just starting dialysis, OR you are switching from peritoneal dialysis to hemodialysis - Your blood access (dialysis port or fistula) can handle adequate blood flow - You are willing to attend all required appointments **You may NOT be eligible if...** - You weigh less than 60 kg (132 lbs) or more than 110 kg (242 lbs) - You have a history of skipping scheduled dialysis sessions - You are scheduled for a kidney transplant or switching to peritoneal dialysis within 2 months - You have had a major surgery or heart event in the last 3 months - You have active infection, HIV, Hepatitis B or C, or a serious blood clotting disorder - You are pregnant or breastfeeding - You have had unstable blood pressure during dialysis recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESolv Multi-Pass Hemodialysis System

Solv Multi-Pass Hemodialysis System


Locations(1)

Carolina Nephrology

Greenville, South Carolina, United States

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NCT07216885


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