[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kaneka Medical America LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":139},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,67,91,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100609441","prospective-multi-center-single-arm-study-for-subjects-with-chronic-subdural-hematoma-treated-with-i-ed-coils-either-alone-or-in-combination-with-burr-holes-or-mini-craniotomy-100609441",false,"NCT07214623","Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy","i-ED COIL Use for Reduction of Chronic Subdural Hematoma Post Market Study","iCURE cSDH","Inclusion Criteria:\n\n* Pre morbid mRS 0-3\n* Chronic subdural symptomatic, requiring intervention\n\nExclusion Criteria:\n\n* Acute subdural hematoma\n* Intercranial mass other than subdural hematoma\n* Females pregnant or breast feeding\n* Compromised survival or inability to complete trial","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","6 Months","OBSERVATIONAL","All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain. Depending on the specific condition patients may also have a surgical procedure, a mini-craniotomy or burr holes where the skull is pierced and the blood clot is drained.",[26,27,28],"Chronic Subdural Hematoma","cSDH","Chronic Subdural Hematomas","NOT_YET_RECRUITING","2025-10-02",{"date":32,"type":33},"2025-10-09","ACTUAL",{"date":35,"type":21},"2025-11-30",{"date":37,"type":21},"2027-05-31",{"name":39,"class":40},"Kaneka Medical America LLC","INDUSTRY",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100282102","post-approval-study-of-lixelle-for-the-treament-of-dialysis-related-amyloidosis-100282102","NCT02952144","Post Approval Study of Lixelle for the Treament of Dialysis-Related Amyloidosis","Treatment of Dialysis-Related Amyloidosis Using Lixelle® β2-microglobulin Apheresis Column","Inclusion Criteria:\n\n* Patients receiving thrice-weekly HD and diagnosed as DRA by one or more of the following 1 to 4 will be included.\n\n  1. Biopsy of any tissue, showing Congo-red positive amyloid fibrils and immunohistochemical stains consistent with β2M\n  2. Shoulder ultrasonography showing rotator cuffs greater than 8 mm in thickness, and \u002For echogenic pads between muscle groups of the rotator cuff\n  3. Two or more diagnoses of the following (1) to (5) (1) Polyarthralgia (2) Carpal tunnel syndrome (3) Trigger finger (4) Dialysis-associated spondylosis ((i) or (ii)) (i) Destructive spondyloarthropathy (DSA) (ii) Spinal stenosis (5) Bone cysts (Bone cysts considered to be caused by other diseases such as osteoarthritis, aneurysmal bone cysts and unicameral bone cysts should be excluded.)\n  4. Biopsy of any tissue, showing Congo-red positive amyloid fibrils, and one diagnosis or surgical history of criterion 3- (1) to (5)\n\nExclusion Criteria:\n\n* Patient who meets any of the following 1 to 7 will be excluded from the study.\n\n  1. Patient diagnosed with rheumatoid arthritis\n  2. Patient diagnosed with osteoporosis\n  3. Patient diagnosed with osteoarthritis\n  4. Patient planning to receive renal transplantation during the study\n  5. Patient for whom adequate anticoagulation cannot be achieved\n  6. Patient for whom extracorporeal circulation therapy is contraindicated, such as those with severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute seizure disorder, or severe uncontrolled hypertension or hypotension\n  7. Patient planning to become pregnant, pregnant, or breast-feeding\n  8. Patient unable to understand or answer the questionnaires even with a proper assistance",{"count":50,"type":21},40,"INTERVENTIONAL",[53],"NA","Dialysis-related amyloidosis (DRA) is a serious complication of long-term hemodialysis (HD). Its pathogenic mechanism involves accumulation of β2-microglobulin (β2M) in the blood. β2M is produced by most cells in the body and is metabolized in the kidney in healthy individuals. However, in HD patients with renal dysfunction, β2M which is not removed entirely by HD accumulates excessively in the blood. Then it forms amyloid fibrils that are deposited in bones, joints, and soft tissues. The fibrils are further modified by advanced glycation end products (AGE), inducing local macrophage infiltration and production of cytokines leading to chronic inflammation and activation of osteoclasts. Consequently, severe complications with various symptoms are developed, which are collectively referred to as DRA.\n\nLixelle® is a whole-blood β2M apheresis column developed to adsorb and eliminate β2M selectively from the blood of DRA patients. The treatment is performed with Lixelle® connected upstream of the dialyzer in series on a HD circuit in every session. The Lixelle® column contains porous cellulose beads with covalently linked hexadecyl alkyl chain ligands, which selectively adsorb β2M, via a molecular sieving effect because of its porous structure and hydrophobic interaction with ligands. Lixelle® has been used to relieve symptoms and prevent the progression of DRA in Japan since 1996, when health insurance coverage and reimbursement for the treatment were approved by Japanese Ministry of Health, Labor, and Welfare. Improvement of the activities of daily living (ADL) and remission of arthralgia by Lixelle® treatment has been shown in several clinical studies.",[56],"Dialysis Amyloidosis","RECRUITING","2025-04-29",{"date":60,"type":33},"2025-04-30",{"date":62,"type":33},"2015-10",{"date":64,"type":21},"2026-12",{"name":39,"class":40},1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":51,"phases":78,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100227240","post-approval-study-of-liposorber-la-15-system-for-the-treatment-of-focal-segmental-glomerulosclerosis-in-children-100227240","NCT02235857","Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children","Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System","FSGS pediatric","Inclusion Criteria:\n\n* A pediatric patient is deemed suitable for inclusion in the study if the patient has FSGS with a GFR ≥ 45 ml\u002Fmin\u002F1.73 m 2 and any of the following:\n\n  * Refractory nephrotic syndrome in which standard treatment options are unsuccessful (i.e., patient is unresponsive to standard corticosteroid and\u002For calcineurin inhibitor therapy for at least 8 weeks resulting in failure to achieve complete or partial remission);\n  * Refractory nephrotic syndrome in which standard treatment options are not well tolerated (i.e., patients intolerant to standard therapies due to severe side effects that negatively affect quality of life without providing an acceptable level of clinical benefit);\n  * Refractory or recurrent nephrotic syndrome in which standard therapy is contraindicated.\n\nor\n\n\\- Pediatric post renal transplant patients with nephrotic syndrome associated with primary FSGS.\n\nExclusion Criteria:\n\n* General Exclusion Criteria\n\n  * Patient is greater than 21 years of age\n  * Parent or patient is unwilling or unable to sign and date the informed consent (Note: Only patients 18-21 years of age may sign the informed consent on their own behalf)\n  * Pregnant, lactating, or planning to become pregnant prior to completing the study (Note: The safety of the use of Liposorber® in pregnant women has not been studied. There may be unknown risks to an embryo\u002Ffetus. Sexually active women of child bearing potential should avoid pregnancy during the use of the Liposorber device and throughout the study duration.)\n  * Unable or unwilling to comply with the follow-up schedule\n  * Simultaneously participating in another investigational drug or device study\n  * Body weight \\\u003C 15 kg (33.1 lbs)\n* Medical Exclusion Criteria\n\n  * Currently being administered ACE inhibitors that cannot be withheld for at least 24 hours prior to each apheresis treatment (Note: The time period to withhold ACE inhibitors should be prolonged, if determined by the treating physician, considering each individual's renal function and the biological half-life of the ACE-inhibitor currently in use.)\n  * Currently being administered antihypertensive drugs other than ACE inhibitors (e.g., Angiotensin II receptor blockers (ARBs) that cannot be withheld on the day of apheresis until after the procedure\n  * Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint or that may cause noncompliance with the study plan or confound the data analysis\n  * Hypersensitivity to dextran sulfate, heparin, or ethylene oxide\n  * Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications\n  * Extracorporeal circulation therapy with Liposorber® LA-15 System cannot be tolerated due to severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute apoplexy, severe uncontrollable hypertension, or severe uncontrollable hypotension\n  * Cardiac impairments such as uncontrolled arrhyth¬mia, unstable angina, decompensated congestive heart failure, or valvular disease\n  * Functional thyroid disease or liver abnormalities\n  * Unresolved systemic or local infection that could affect the clinical study outcomes","21 Years",{"count":77,"type":21},35,[53],"Liposorber® LA-15 System is a blood purification therapy that selectively removes malignant lipoproteins including low density lipoprotein from circulating blood flow and rapidly reduces the plasma cholesterol level. The system was originally developed for the treatment of patients with serious dyslipidemia such as familial hypercholesterolemia and then applied to improve the dyslipidemia, a common complication of nephrotic syndrome and found to bring about improvement not only with the dyslipidemic condition but the nephrotic condition (e.g, proteinuria and hypoproteinemia).\n\nAlthough the definitive mechanism by which the system may relieve nephrotic syndrome is unknown, it has been recognized as one of alternative therapies for refractory nephrotic syndrome including focal segmental glomerulosclerosis (FSGS) in Japan and referred in the Guidelines for the Treatment of Nephrotic Syndrome endorsed by The Japanese Society of Nephrology.\n\nThis study is conducted as a post approval study imposed by Humanitarian Device Exemption (HDE) order to confirm the safety and efficacy of the Liposorber® LA-15 System in the treatment of drug-resistant pediatric primary FSGS.",[81],"Focal Segmental Glomerulosclerosis",[83],"pediatric, renal transplantation, recurrence, drug-resistant",{"date":60,"type":33},{"date":86,"type":33},"2015-05-03",{"date":88,"type":21},"2028-07-03",{"name":39,"class":40},12,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":98,"minAge":18,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":51,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100560688","a-feasibility-study-to-evaluate-the-safety-of-the-knp-1000-apheresis-system-in-severe-preeclampsia-100560688","NCT06580405","A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Severe Preeclampsia","A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Patients With Preeclampsia With Severe Features","Inclusion Criteria:\n\nA participant is deemed suitable for inclusion in the investigation if she meets the following criteria:\n\n1. Pregnant woman ≥ 23 0\u002F7 and \\< 32 0\u002F7 weeks gestation, aged 18 to 45 years, hospitalized for preeclampsia at time of enrollment.\n2. Severe hypertension ever defined by resting systolic BP ≥ 160 mm Hg and\u002For diastolic BP ≥ 110 mm Hg on two occasions measured at least 4 hours apart.\n3. Proteinuria, defined as ≥ 300 mg protein in a 24-hour urine collection or ≥ 0.3 protein\u002Fcreatinine ratio.\n4. Provision of signed and dated informed consent form.\n\nExclusion Criteria:\n\nA participant will be excluded from the investigation if any of the following maternal or fetal criteria are met.\n\nMaternal Exclusion Criteria:\n\n1. Documented history of chronic hypertension, defined as systolic BP ≥ 140mmHg and\u002For systolic BP ≥ 90 mmHg before pregnancy or prior to 20 weeks of gestation.\n2. Documented history of proteinuria prior to pregnancy or prior to 20 weeks of gestation.\n3. Taking any form of angiotensin cascade blocker or angiotensin-converting enzyme (ACE) inhibitor at time of enrollment.\n4. Documented history of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease.\n5. Actively receiving therapeutic anticoagulation therapy or within the therapeutic window after ceasing anticoagulation therapy at the time of enrollment.\n6. Any condition which, in the opinion of the Investigator, would necessitate immediate delivery within 24 hours.\n7. Signs or history of cerebral nervous system dysfunction, including seizures, cerebral edema (previously confirmed by computed tomography scan or magnetic resonance imaging per medical records).\n8. Confirmed or suspected diagnosis of pulmonary edema at time of enrollment.\n9. Diagnosis of HELLP syndrome.\n10. Thrombocytopenia (platelet count \\< 100,000\u002Fmm3) at time of enrollment.\n11. Anemia defined as hemoglobin \\< 8 g\u002FdL at time of enrollment.\n12. Absent or reverse flow on umbilical Doppler ultrasound exam at the time of screening, or documented history of negative or reverse flow during the current gestation period.\n13. Diagnosis of placenta previa during the current gestation period.\n14. Preterm labor at or before time of screening.\n15. Documented medical history of active hepatitis B virus, hepatitis C virus (HCV), syphilis, tuberculosis infection, or human immunodeficiency virus (HIV) positive status.\n16. Any condition that the Investigator deems a risk to the study participant or fetus in completing the investigation.\n17. Hypersensitivity to dextran sulfate cellulose or heparin.\n18. Multiple gestation.\n19. Documented history of familial hypercholesterolemia.\n20. Suspicion or diagnosis of placental abruption during the current gestation.\n21. Patients who have received the drug treatment not recommended by the American College of Obstetricians and Gynecologists (ACOG) practice bulletin Gestational Hypertension and Preeclampsia (the clinical management guidelines) within 6 months prior to enrollment.\n22. Patients who have participated in another clinical trial within 6 months prior to enrollment.\n\nFetal Exclusion Criteria:\n\n1. Documented record of chromosomal anomalies.\n2. Identifiable structural fetal abnormalities present at time of screening or a record of such abnormalities prior to enrollment.\n3. Oligohydramnios, defined as Amniotic fluid index (AFI) less than 5 cm when measured using the four-quadrant method at time of enrollment.\n4. Fetal growth restriction (FGR) defined as estimated fetal weight (EFW) below the 5th percentile for gestational age.","FEMALE","45 Years",{"count":101,"type":21},13,[53],"The study will primarily evaluate safety of the KNP-1000 apheresis system for pregnant women and their fetuses diagnosed with preeclampsia with severe features between 23- and 32-weeks' gestation (very preterm).",[105],"Pre-Eclampsia, Severe","2025-03-03",{"date":108,"type":33},"2025-03-05",{"date":110,"type":21},"2025-05-31",{"date":112,"type":21},"2028-06-30",{"name":39,"class":40},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":51,"phases":124,"briefSummary":125,"conditions":126,"keywords":127,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100367526","post-approval-study-for-treatment-of-drug-resistant-adult-and-pediatric-primary-fsgs-using-the-liposorber-la-15-system-100367526","NCT04065438","Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System","Treatment of Drug-resistant Adult and Pediatrc Primary Focal Segmental Glomerulosclerosis and Post -Transplant Recurrence Using the LIPOSORBER® LA-15 System","FSGSALLAGE","Inclusion Criteria:\n\nA patient is deemed suitable for inclusion in the study if the patient has nephrotic syndrome associated with primary FSGS when:\n\n• Standard treatment options, including corticosteroid and\u002For calcineurin inhibitors, are unsuccessful or not well tolerated and the patient's glomerular filtration rate (GFR) ≥ 45 ml\u002Fmin\u002F1.73 m2.\n\nor\n\n• The patient is post renal transplantation.\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria\n\n1. Patient is greater than 75 years of age at the start of the treatment period or less than 22\n2. The patient is unwilling or unable to sign and date the informed consent\n3. Pregnant, lactating, or planning to become pregnant prior to completing the study (Note: The safety of the use of LIPOSORBER® in pregnant women has not been studied. There may be unknown risks to an embryo\u002Ffetus. Sexually active women of childbearing potential should avoid pregnancy during the use of the LIPOSORBER device and throughout the study duration.)\n4. Unable or unwilling to comply with the follow-up schedule\n5. Simultaneously participating in another investigational drug or device study\n6. Body weight \\\u003C 15 kg (33.1 lbs)\n\nMedical Exclusion Criteria\n\n1. Currently being administered ACE inhibitors that cannot be withheld for at least 24 hours prior to each apheresis treatment (Note: The time period to withhold ACE inhibitors should be prolonged, if determined by the treating physician, considering each individual's renal function and the biological half-life of the ACE-inhibitor currently in use.)\n2. Currently being administered antihypertensive drugs other than ACE inhibitors (e.g., ARBs) that cannot be withheld on the day of apheresis until after the procedure\n3. Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint or that may cause noncompliance with the study plan or confound the data analysis\n4. Hypersensitivity to dextran sulfate, heparin, or ethylene oxide\n5. Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications\n6. Extracorporeal circulation therapy with LIPOSORBER® LA-15 System cannot be tolerated due to severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute apoplexy, severe uncontrollable hypertension, or severe uncontrollable hypotension Note: Severe uncontrollable hypotension\u002Fhypertension indicates the cases with systolic and\u002For diastolic blood pressure ≤ 5th percentile for age, gender, and height.\n7. Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease\n8. Functional thyroid disease or liver abnormalities\n9. Unresolved systemic or local infection that could affect the clinical study outcomes","75 Years",{"count":77,"type":21},[53],"This multicenter, prospective, single-arm clinical study will evaluate the probable benefit and safety of the LIPOSORBER® LA-15 System for the treatment of adult patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when the standard treatment options, including corticosteroid and\u002For calcineurin inhibitors treatments, have been unsuccessful or not well tolerated, and the patient has a GFR ≥ 45 ml\u002Fmin\u002F1.73m2, or the patient has post-renal transplant recurrence. Treatment for FSGS is considered unsuccessful if the patient is unresponsive to standard therapy (e.g., at least 8 weeks of corticosteroids) and fails to achieve complete or partial remission. A standard treatment is considered not well tolerated if the patient experiences severe side effects without providing an acceptable level of clinical benefit.",[81],[128,129],"FSGS","Liposorber","2024-10-07",{"date":132,"type":33},"2024-10-09",{"date":134,"type":33},"2020-01-01",{"date":136,"type":21},"2028-06-01",{"name":39,"class":40},10,""]