Solv Multi-Pass Hemodialysis System In-Center Clinical Study
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.
• 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