Solv Multi-Pass Hemodialysis System In-Center Clinical Study
ConditionEnd Stage Renal Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMozarc Medical US LLC
About this trial
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 criteria
Qualifiers
Subjects able and willing to give Informed Consent and interested to participate in the study
Subject aged 18 years or older
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Solv Multi-Pass Hemodialysis System
Treatment groups
46 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov