Solv Multi-Pass Hemodialysis System In-Center Clinical Study
Mozarc Medical US LLC
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 adequ…
Interventions
- DeviceSolv Multi-Pass Hemodialysis System
Solv Multi-Pass Hemodialysis System
Location
- Carolina NephrologyGreenville, South Carolina