[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07216885":3,"trial-entities:NCT07216885":138,"trial-summary:NCT07216885":142},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":41,"sex":72,"minimum_age":73,"maximum_age":16,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":110,"locations":113,"central_contacts":130,"overall_officials":135,"references":136,"see_also_links":137},"NCT07216885","MDT22047","Solv Multi-Pass Hemodialysis System In-Center Clinical Study","RECRUITING","2026-07","2026-03","2026-04-01","2026-01-13","Mozarc Medical US LLC","INDUSTRY",true,"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\u002For 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.",null,[18],"End Stage Renal Disease",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},46,"ESTIMATED",[28],{"type":29,"name":30,"description":30,"armGroupLabels":31},"DEVICE","Solv Multi-Pass Hemodialysis System",[32],"Solv Multi-Pass Hemodialysis System In-Center Subjects",[34,38],{"measure":35,"description":36,"timeFrame":37},"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.","through study completion, an average of 1 year",{"measure":39,"description":40,"timeFrame":37},"Primary Performance Endpoint","Evaluate the mean single pool (sp)Kt\u002FV for subjects undergoing conventional In-Center HD with the Solv Multi-Pass Hemodialysis System during the eight-week study Phase.",[42,45,48,51,54,57,60,63,66,69],{"measure":43,"description":44,"timeFrame":37},"Serious adverse events and all device and\u002For therapy related adverse events","Quantify all serious adverse events and all device and\u002For 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",{"measure":46,"description":47,"timeFrame":37},"Uremic toxin profile","Characterize uremic toxin profile of urea, β-2 microglobulin and myoglobin",{"measure":49,"description":50,"timeFrame":37},"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",{"measure":52,"description":53,"timeFrame":37},"Nutritional status","Evaluate nutritional status by characterizing pre-post session albumin and change in body mass index (BMI)",{"measure":55,"description":56,"timeFrame":37},"Inflammation markers","Assess inflammation markers by characterizing pre-session values of C-reactive protein (CRP)",{"measure":58,"description":59,"timeFrame":37},"Volume of UF removed","Confirm that the volume of UF removed as indicated by the Solv System will be within 10% of target UF volume entered into the device per session, accounting for prescribed estimated dry weight, treatment time, and rinse back volume",{"measure":61,"description":62,"timeFrame":37},"Use of intradialytic medications","Summarize the use of intradialytic anticoagulants and erythropoietin, phosphate binders and iron doses",{"measure":64,"description":65,"timeFrame":37},"Patient-reported outcome measures with KDQOL-36","Quantify patient-reported outcome measures on KDQOL-36 questionnaire to assess patient quality of life and satisfaction, along with physicial and mental health. The KDQOL will be collected at baseline and IC- weeks 1, 4, and 8 for comparison",{"measure":67,"description":68,"timeFrame":37},"Patient-reported outcome measures with Dialysis Recovery Time Questionnaire","Quantify patient-reported outcome measures on dialysis recovery time to assess amoujnt of time it takes for each subject to recover from a dialysis session. The DRT questionnaire will be collected at baseline and In-Center Weeks 1, 4, \\& 8 for comparison.",{"measure":70,"description":71,"timeFrame":37},"User Experience with Solv","Characterize the user experience via questionnaire (e.g., Solv set-up, recharging process, alarm management). The questionnaire will be provided to a sampling of users.","ALL","18 Years",false,{"inclusion":76,"exclusion":86,"raw_text":109},[77,78,79,80,81,82,83,84,85],"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\u002Fmin","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",[87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108],"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","Subjects with any major surgery or major adverse cardiac event within 3 months of screening","Subjects with hemodynamic instability, defined as repeated hypo\u002Fhypertension, in the past 30 days from screening","Subjects with active or ongoing infection, in the opinion of the Investigator","Subjects with known Hepatitis B, C or HIV infection","Subject with documented coagulation disorders, active or bleeding risk or who is intolerant to heparin","Subjects who are currently participating or have previously participated in another interventional clinical trial in the past 4 weeks from screening","Subjects with any comorbidities possibly conflicting with the study purpose or procedures, in the opinion of the Investigator","Subjects who are pregnant or lactating or any patient with a childbearing potential who refuses to use medically acceptable means of contraception","Subjects with an active, malignant disease and whose life expectancy is \\\u003C 6 months, in the opinion of the investigator","Subjects with a hemoglobin \\\u003C 9 gm\u002Fdl in the past 30 days from screening","Subjects with significant intradialytic hypotension in 30 days from screening","Subjects with shock within 30 days from screening","Subjects with active seizures in the last 6 months from screening","Subjects with history of hemolytic anemia or thrombocytopenia","Subjects with vascular access dysfunction (switching ports (reverse lines or catheter replacement) in 30 days prior to screening, multiple tPA (tissue plasminogen activator) administrations) or patient who has had a thrombectomy procedure within 30 days prior to screening","Subjects with a documented history of congestive heart failure with symptoms consistent with NYHA Class III or IV, according to the investigator, or documented severe left ventricular dysfunction","Subjects with fluid overload due to intractable ascites secondary to liver cirrhosis","Subjects with active, life-threatening rheumatologic disease","Inclusion Criteria:\n\n* Subjects able and willing to give Informed Consent and interested to participate in the study\n* Subject aged 18 years or older\n* Subjects meets one of the following three conditions:\n\n  * 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\n  * Incident end stage renal disease (ESRD) patients who have been prescribed HD therapy\n  * Subjects on peritoneal dialysis who require conversion to hemodialysis, according to the investigator\n* Subjects who have adequate access, capable of providing a blood flow rate of at least 300 mL\u002Fmin\n* Subject understands the nature of the procedures and the requirements of the study protocol\n* Subject is willing and able to comply with the protocol requirements and return to the treatment center for all required treatments and clinical evaluations\n\nExclusion Criteria:\n\n* Subjects with baseline dry weight of ≤ 60 kg or ≥ 110 kg\n* Subjects with a documented history of non-compliance to scheduled hemodialysis sessions or clinic visits\n* 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\n* Subjects with unstable electrolytes or acid base balance, in the opinion of the investigator\n* Subjects with any major surgery or major adverse cardiac event within 3 months of screening\n* Subjects with hemodynamic instability, defined as repeated hypo\u002Fhypertension, in the past 30 days from screening\n* Subjects with active or ongoing infection, in the opinion of the Investigator\n* Subjects with known Hepatitis B, C or HIV infection\n* Subject with documented coagulation disorders, active or bleeding risk or who is intolerant to heparin\n* Subjects who are currently participating or have previously participated in another interventional clinical trial in the past 4 weeks from screening\n* Subjects with any comorbidities possibly conflicting with the study purpose or procedures, in the opinion of the Investigator\n* Subjects who are pregnant or lactating or any patient with a childbearing potential who refuses to use medically acceptable means of contraception\n* Subjects with an active, malignant disease and whose life expectancy is \\\u003C 6 months, in the opinion of the investigator\n* Subjects with a hemoglobin \\\u003C 9 gm\u002Fdl in the past 30 days from screening\n* Subjects with significant intradialytic hypotension in 30 days from screening\n* Subjects with shock within 30 days from screening\n* Subjects with active seizures in the last 6 months from screening\n* Subjects with history of hemolytic anemia or thrombocytopenia\n* Subjects with vascular access dysfunction (switching ports (reverse lines or catheter replacement) in 30 days prior to screening, multiple tPA (tissue plasminogen activator) administrations) or patient who has had a thrombectomy procedure within 30 days prior to screening\n* Subjects with a documented history of congestive heart failure with symptoms consistent with NYHA Class III or IV, according to the investigator, or documented severe left ventricular dysfunction\n* Subjects with fluid overload due to intractable ascites secondary to liver cirrhosis\n* Subjects with active, life-threatening rheumatologic disease",[111,112],"ADULT","OLDER_ADULT",[114],{"facility":115,"status":7,"city":116,"state":117,"zip":118,"country":119,"contacts":120,"geoPoint":127},"Carolina Nephrology","Greenville","South Carolina","29605","United States",[121,125],{"name":122,"role":123,"phone":124},"Barry Gorlitsky","CONTACT","862-271-1844",{"name":122,"role":126},"PRINCIPAL_INVESTIGATOR",{"lat":128,"lon":129},34.85262,-82.39401,[131],{"name":132,"role":123,"phone":133,"email":134},"Sr. Clinical Research Director","877-211-1850","mike.serle@mozarcmedical.com",[],[],[],{"nct_id":4,"conditions":139,"biomarkers":141},[140],"Chronic Kidney Disease, Stage 5",[],{"nct_id":4,"found":14,"summary":143,"prompt_version":153},{"design":144,"status":145,"heading":146,"summary":147,"follow_up":148,"word_count":149,"commitments":150,"compensation":151,"drugs_mentioned":152},"This is a single-arm, open-label study, meaning all 46 participants will receive the Solv Multi-Pass Hemodialysis System, and both you and the study team will know what treatment you are receiving.","completed","Solv Multi-Pass Hemodialysis System for End Stage Renal Disease","This study is testing a new device called the Solv Multi-Pass Hemodialysis System for people with End Stage Renal Disease (ESRD), also known as kidney failure. The goal is to see how safe and effective this new system is over about one year. You might be able to join if you are 18 or older and have ESRD, whether you're new to dialysis or already receiving it in a clinic. The study will look at how well the system works and if there are any side effects. There are no specific biomarkers (biological signs) being detected for eligibility.","Your safety and the device's performance will be measured through study completion, which is an average of one year.",98,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]