Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07216885

Solv Multi-Pass Hemodialysis System In-Center Clinical Study

Led by Mozarc Medical US LLC · Updated on 2026-04-01

46

Participants Needed

1

Research Sites

24 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Solv Multi-Pass Hemodialysis System In-Center Clinical Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to give informed consent and interested in participating
  • Age 18 years or older
  • Meet one of the following: stable end stage renal disease patients treated with maintenance hemodialysis for at least three months; newly prescribed hemodialysis patients; or patients on peritoneal dialysis requiring switch to hemodialysis
  • Have adequate vascular access capable of blood flow of at least 300 mL/min
  • Understand the study procedures and requirements
  • Willing and able to comply with protocol and attend all treatments and evaluations
Not Eligible

You will not qualify if you...

  • Baseline dry weight 60 kg or less, or 110 kg or more
  • History of non-compliance with hemodialysis or clinic visits
  • Scheduled for living kidney transplant, planned switch to peritoneal dialysis, or needing single needle dialysis within next two months
  • Unstable electrolytes or acid base balance
  • Major surgery or major adverse cardiac event within 3 months prior to screening
  • Hemodynamic instability with repeated low or high blood pressure in past 30 days
  • Active infection
  • Known Hepatitis B, Hepatitis C, or HIV infection
  • Coagulation disorders, bleeding risk, or heparin intolerance
  • Participation in another interventional trial within 4 weeks prior to screening
  • Comorbidities conflicting with study purpose or procedures
  • Pregnant, lactating, or childbearing potential without contraception
  • Active malignant disease with life expectancy less than 6 months
  • Hemoglobin less than 9 gm/dl in past 30 days
  • Significant intradialytic hypotension in past 30 days
  • Shock within past 30 days
  • Active seizures in past 6 months
  • History of hemolytic anemia or thrombocytopenia
  • Vascular access dysfunction or recent catheter procedures within 30 days
  • Congestive heart failure with severe symptoms or severe left ventricular dysfunction
  • Fluid overload due to intractable ascites from liver cirrhosis
  • Active, life-threatening rheumatologic disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Carolina Nephrology

Greenville, South Carolina, United States, 29605

Actively Recruiting

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Research Team

S

Sr. Clinical Research Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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