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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Solv Multi-Pass Hemodialysis System
DeviceSolv Multi-Pass Hemodialysis System
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: Solv Multi-Pass Hemodialysis System In-Center SubjectsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint
Evaluate the number of serious device-related adverse events that occur during the In-Center Phase of the study, to confirm there are no additional risks associated with the Solv System implementation of sorbent-based HD.
Time frame
through study completion, an average of 1 year2
Primary Performance Endpoint
Evaluate the mean single pool (sp)Kt/V for subjects undergoing conventional In-Center HD with the Solv Multi-Pass Hemodialysis System during the eight-week study Phase.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Serious adverse events and all device and/or therapy related adverse events
Quantify all serious adverse events and all device and/or therapy related adverse events which occur during the Run-in and In-Center Phase, regardless of relationship to the Solv Multi-Pass Hemodialysis System or seriousness
Time frame
through study completion, an average of 1 year2
Uremic toxin profile
Characterize uremic toxin profile of urea, β-2 microglobulin and myoglobin
Time frame
through study completion, an average of 1 year3
Electrolyte balance and evaluate mineral metabolism
Verify electrolyte balance and evaluate mineral metabolism by characterizing pre-post session sodium, chloride, potassium, calcium, magnesium, bicarbonate, phosphate and glucose
Time frame
through study completion, an average of 1 year4
Nutritional status
Evaluate nutritional status by characterizing pre-post session albumin and change in body mass index (BMI)
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov