[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Angiodynamics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":209},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,42,71,96,118,138,168,186],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100643038","irreversible-electroporation-ire-for-the-treatment-of-lower-urinary-tract-symptoms-luts-in-men-with-benign-prostatic-hyperplasia-bph-100643038",false,"NCT07640776","Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)","RELIEF","Inclusion Criteria:\n\n1. Male, age ≥50 years.\n2. Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH).\n3. International Prostate Symptom Score (IPSS) ≥13 at screening.\n4. Peak urinary flow rate (Qmax) ≤12 mL\u002Fsec on non-catheterized free flow with voided volume ≥125 mL.\n5. Post-void residual (PVR) ≤250 mL.\n6. Prostate volume between 30 cc and 80 cc by transrectal ultrasound (TRUS) or Magnetic Resonance Imaging (MRI).\n7. Willing and able to comply with all study procedures and follow-up requirements.\n8. Able to provide written informed consent.\n9. Life expectancy ≥10 years.\n\nExclusion Criteria:\n\n1. Patients with ≥ Grade Group 2 prostate cancer (≥ Gleason score 7).\n2. Patients with Grade Group 1 prostate cancer (Gleason score 6) on active surveillance for less than 1 year.\n3. Patients with PSA ≥10 ng\u002FmL or PSA density ≥0.15 ng\u002FmL2.\n4. Prior surgical or minimally invasive intervention for BPH (e.g., TURP, Rezūm™, UroLift®, laser therapy).\n5. Presence of urethral stricture or bladder neck contracture.\n6. Patients with a history of pelvic radiation\u002Firradiation.\n7. Patients with compromised renal function (serum creatinine level \\>1.8 mg\u002FdL or upper-tract disease).\n8. Obstructing median lobe intravesical prostatic protrusion (IPP) with \\>1 cm assessed by TRUS or MRI.\n9. Active urinary tract infection, prostatitis, or gross hematuria within 3 months of enrollment.\n10. Active need of catheterization.\n11. Known or suspected neurogenic bladder or underlying neurologic disease affecting bladder function (e.g., Parkinson's disease, multiple sclerosis, stroke with residual urinary symptoms).\n12. History of bladder cancer or other urological malignancy.\n13. Implanted electrical devices (e.g., pacemaker, defibrillator, neurostimulator) incompatible with IRE energy delivery.\n14. Uncorrected bleeding diathesis or current therapeutic anticoagulation that cannot be safely interrupted.\n15. Current use of BPH medications unless on a stable dose for ≥6 weeks (alpha-blockers, anticholinergics, beta-3 adrenergic agonists) or ≥6 months (5-alpha reductase inhibitors, phosphodiesterase type 5 inhibitors) prior to baseline, with no planned changes during study follow-up.\n16. Prior rectal or pelvic surgery that may interfere with treatment delivery or evaluation.\n17. Desire to preserve future fertility.\n18. Severe or uncontrolled comorbidities (e.g., NYHA class III\u002FIV heart failure, uncontrolled diabetes, severe pulmonary disease) that, in the opinion of the investigator, would increase study risk or confound outcomes.\n19. Participation in another clinical trial involving an investigational drug or device within 30 days prior to enrollment.\n20. Patients who are members of a vulnerable population, such as the cognitively challenged or incarcerated, that could expose them to undue influence, coercion, or inability to provide informed consent.","MALE","50 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study will evaluate the safety and effectiveness of using Irreversible Electroporation (IRE) for the treatment of symptomatic benign prostatic hyperplasia (BPH).",[26],"Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)",[28,29],"Lower Urinary Tract Symptoms (LUTS)","Benign Prostatic Hyperplasia (BPH)","NOT_YET_RECRUITING","2026-06-09",{"date":33,"type":34},"2026-06-11","ACTUAL",{"date":36,"type":20},"2026-09",{"date":38,"type":20},"2031-06",{"name":40,"class":41},"Angiodynamics, Inc.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100614488","acute-pulmonary-embolism-treatment-with-the-alphavac-multipurpose-mechanical-aspiration-system-and-the-alphareturn-blood-management-system-evaluation-of-safety-and-effectiveness-100614488","NCT07280247","Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness","Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness (APEX-Return)","APEX-Return","Inclusion Criteria:\n\nA potential subject will be included in the study if he\u002Fshe meets all the following inclusion criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Subject is 18 years of age and older.\n3. Subject presents clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.\n4. Subject has a diagnosis of pulmonary embolism detected from computed tomography angiography (CTA).\n5. Subject has a RV\u002FLV ratio of 0.9 or higher.\n6. Subject has a systolic blood pressure (SBP) of 90mmHg or higher.\n7. Subject has a heart rate of 130 beats per minute (BPM) or less prior to the procedure.\n8. Subject is deemed medically eligible for interventional procedure(s) per institutional guidelines and\u002For clinical judgment.\n\nExclusion Criteria:\n\nA potential subject will be excluded from the study if he\u002Fshe meets any of the following exclusion criteria:\n\n1. Subjects who are or may be pregnant as determined by a positive pregnancy test or who are breastfeeding.\n2. Subjects who have any contraindication to systemic or therapeutic doses of heparin or anticoagulants.\n3. Subjects who have used thrombolytics in the 30 days prior to the baseline CTA.\n4. Subjects who have pulmonary hypertension with peak pulmonary artery pressure (PAP) \\> 70 mmHg.\n5. Subjects who have FiO2 requirement \\> 44% or \\> 6 LPM to keep oxygen saturations \\> 90%.\n6. Subjects with hematocrit \\\u003C 28% within 6 hours of index procedure.\n7. Subjects with platelets count \\\u003C 100,000\u002FμL.\n8. Subjects with serum creatinine \\> 1.8 mg\u002FdL.\n9. Subjects with International Normalized Ratio (INR) \\> 3.\n10. Subjects who have undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) \\> 15.\n11. Subjects with the presence of cancer requiring active chemotherapy.\n12. Subjects with known bleeding diathesis or coagulation disorder.\n13. Subjects who have had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.\n14. Subjects with a history of severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, underlying lung disease that is oxygen dependent, heparin-induced thrombocytopenia (HIT) and\u002For chronic left heart disease with left ventricular ejection fraction ≤ 30%.\n15. Subjects with known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.\n16. Subject requires vasopressor after fluids to keep pressure ≥ 90mmHg.\n17. Subjects with left bundle branch block.\n18. Subjects who have intracardiac lead in the right ventricle or atrium.\n19. Evidence such as imaging or other that suggest the subject is not appropriate for this procedure.\n20. Subjects that have life expectancy \\\u003C 90 days, in the opinion of the investigator at the time of enrollment.\n21. Subjects dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).\n22. Participation in another investigational study.","ALL","18 Years",{"count":53,"type":20},39,[23],"The investigation is intended to evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used in conjunction with the cleared AlphaVac MMA F1885 System for the treatment of acute pulmonary embolism.",[57],"Pulmonary Embolism Acute",[59,60],"pulmonary embolism","alphareturn","RECRUITING","2026-05-07",{"date":64,"type":34},"2026-05-11",{"date":66,"type":34},"2026-03-30",{"date":68,"type":20},"2026-12",{"name":40,"class":41},6,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100614623","percutaneous-angiovac-vegetation-extraction-pave-to-remove-right-heart-vegetations-in-patients-with-infective-endocarditis-100614623","NCT07282002","Percutaneous AngioVac Vegetation Extraction (PAVE) to Remove Right Heart Vegetations in Patients With Infective Endocarditis","Feasibility Protocol for Percutaneous AngioVac Vegetation Extraction (PAVE) to Remove Right Heart Vegetations in Patients With Infective Endocarditis","PAVE","Inclusion Criteria:\n\n1. Subject age ≥ 18 years\n2. Subject provides a signed and dated Informed Consent Form\n3. Subject has a diagnosis of native infective endocarditis\n4. Subject has presence of bacteremia with valvular (tricuspid or pulmonic) vegetations \\> 1 cm confirmed by transesophageal echocardiogram (TEE) or transthoracic echocardiogram (TTE) with the presence of septic emboli\n5. Subject has no underlying terminal illness and subject is deemed medically eligible for interventional procedure(s) per institutional guidelines and\u002For clinical judgment\n\nExclusion Criteria:\n\n1. Subject requires debulking of vegetation on cardiac leads\n2. Subject has a prior history of ischemic\u002Fhemorrhagic stroke (within 3 months)\n3. Subject has a coagulation disorder\n4. Subject has arterial septic emboli\n5. Subject has cerebral septic embolism\n6. Subject has preoperative intubation due to ongoing hypoxemic respiratory failure\n7. Subject has fungal endocarditis\n8. Subject has atrial septal defect\n9. Subject has medically refractory right-sided heart failure secondary to valvular dysfunction (SCAI SHOCK Stage Classification D or E)\n10. Subject has planned valvular replacement\u002Frepair\n11. Subject has prosthetic valves and\u002For annular abscesses\n12. Subject has epidural abscesses\n13. Subject is pregnant or breastfeeding",{"count":80,"type":20},30,[23],"The investigation aims to demonstrate initial safety and efficacy of the AngioVac System for the removal of vegetation in the right heart in patients with infective endocarditis.",[84],"Infective Endocarditis (IE)",[86,87],"AngioVac","Infective endocarditis (IE)","2026-04-17",{"date":90,"type":34},"2026-04-22",{"date":92,"type":20},"2026-04",{"date":94,"type":20},"2027-03",{"name":40,"class":41},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":50,"minAge":4,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100629266","auryon-atherectomy-system-with-standard-balloon-angioplasty-versus-standard-balloon-angioplasty-alone-in-europe-100629266","NCT07472439","Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone in Europe","Randomized Controlled Trial of the Auryon Atherectomy System Used in Combination With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia","AMBITION BTK","Inclusion Criteria:\n\n* Age of subject is ≥ 18.\n* Estimated life expectancy ≥1 year.\n* Subject is able and willing to comply with all assessments in the study.\n* Subject has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.\n* Rutherford Category classification of 4 or 5 of the target limb.\n* Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guidelines.\n\nAngiographic Inclusion Criteria\n\n* Target lesion that is located in a native, de novo infra-popliteal artery (extending from P3 of the popliteal artery to the margin of the ankle mortise).\n* Target lesions(s) must be viewed angiographically and have 50-100% stenosis.\n* Only a single lesion is included in the study per subject.\n* The vessel segment distal to the target lesion must be patent all the way to the ankle, with no significant lesion (≥ 50% stenosis).\n* Lesion length ≥50mm and ≤300mm.\n* Intraluminal crossing of the lesion. Successful crossing is defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations. If this is not certain, IVUS or OCT may be used to verify this at the operator's discretion.\n* Target Lesion reference vessel diameter (RVD) between 1.5mm - 4.5mm by investigator estimate.\n\nExclusion Criteria:\n\n* Target lesion is in a vessel graft or synthetic graft.\n* Treatment of target lesion with radial access.\n* Planned target limb major amputation (above-the-ankle).\n* Acute limb ischemia or required thrombolysis as a primary treatment modality of the target limb.\n* History of prior endovascular or surgical procedure on the index limb within 30 days prior to enrollment or planned within 30 days of the index procedure.\n* Subject is pregnant or breastfeeding. (Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.)\n* Subject has a known coagulopathy or has bleeding diatheses\u002Fdisorder, thrombocytopenia with platelet count less than 100,000\u002Fmicroliter \u002F less than 80,000K.\n* Subject in whom antiplatelet or anticoagulant therapy is contraindicated.\n* Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.\n* Myocardial infarction within 60 days prior to enrollment.\n* History of stroke\u002FCVA\u002FTIA within 60 days prior to enrollment.\n* History of thrombolytic therapy within 14 days of enrollment.\n* Subject has acute or chronic renal disease defined as serum creatinine of \\>2.5 mg\u002FdL or \\>220 umol\u002FL, or is on dialysis.\n* Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.\n* Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the study requirements and evaluations pre- and post-treatment.\n* Subject experiencing ongoing cardiac problems that per the investigator judgment would not make the subject ideal per the procedure.\n* Subject has evidence of intracranial or gastrointestinal bleeding within the past 3 months.\n\nAngiographic Exclusion Criteria\n\n* Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or P1-P2 segments of the popliteal arteries with \\\u003C50% residual stenosis with no serious angiographic complications (e.g., embolism or dissection) prior to treatment of the target lesion.\n* Residual stenosis, and\u002For serious angiographic complications (e.g., embolism) prior to the investigational device usage.\n* The use of adjunctive devices to treat the target lesion other than the investigative Auryon laser catheter and\u002For PTA devices, such as scoring balloons, drug-eluting balloons, re-entry devices, lithotripsy devices, or other atherectomy devices (with the exception of bailout stents for Class C\u002FD dissections).\n\nSubjects that do not meet eligibility criteria for the randomized controlled trial are eligible to be enrolled in the observational study.\n\nObservational Study Inclusion Criteria:\n\n* Subjects intended to be treated with the Auryon Atherectomy System for de-novo, restenotic or ISR lesions of the infra-popliteal arteries.\n* Subjects presenting with symptomatic PAD with claudication or CLI by Rutherford Category 2 - 6 of the target limb.\n* Age of subject is ≥ 18.\n* Subject has been informed of the nature of the study, agrees to participate, and has signed the approved study consent form.\n\nObservational Study Exclusion Criteria:\n\n* Subjects with any medical condition that would make him\u002Fher an inappropriate candidate for treatment with Auryon Atherectomy System as per Instructions for Use (IFU) or investigator's opinion.\n* Subject is pregnant or breastfeeding. (Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.)\n* Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.",{"count":105,"type":20},50,[23],"The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages. The main question it aims to answer is: Is treatment with Auryon Atherectomy System more effective than angioplasty alone in preventing death, amputation, revascularization and improving patency? Researchers will compare the Auryon Atherectomy System with balloon angioplasty to balloon angioplasty alone.",[109],"Peripheral Arterial Disease","2026-03-13",{"date":112,"type":34},"2026-03-16",{"date":114,"type":20},"2026-05",{"date":116,"type":20},"2030-05",{"name":40,"class":41},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":50,"minAge":4,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":107,"conditions":127,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},"100575870","phase-4-auryon-atherectomy-system-with-standard-balloon-angioplasty-versus-standard-balloon-angioplasty-alone-100575870","NCT06777901","Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone",{"count":124,"type":20},224,[126],"PHASE4",[128],"Peripheral Arterial Diseases","2026-01-07",{"date":131,"type":34},"2026-01-08",{"date":133,"type":34},"2025-04-21",{"date":135,"type":20},"2029-04",{"name":40,"class":41},9,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":153,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100607668","international-study-on-treatment-of-patients-with-metastatic-colorectal-liver-lesions-patients-with-ire-100607668","NCT07191548","International Study on Treatment of Patients With Metastatic Colorectal Liver Lesions Patients With IRE","Treatment of LIVER METastases From Colorectal Cancer by IRreversible Electroporation: A Prospective, International, Multi-centre Cohort Study.","LIVERMET-IRE","Inclusion Criteria:\n\n* Patients aged 18 years and over, able to provide informed consent and with histological confirmation of a diagnosis of colorectal cancer from primary tumour.\n* Liver lesions demonstrating radiological characteristics (on magnetic resonance scan) of colorectal hepatic metastases without requirement for biopsy. In the setting of an intact liver, patients with up to four metastases ≤ 4cm in size are eligible for inclusion. In the setting of proposed resection plus ablation, up to two metastases ≤ 4cm in size. In the setting of recurrence after prior hepatectomy up to two metastases ≤ 4cm in size.\n* Eastern Co-operative Oncology Group (ECOG) Score ≤ 2.\n* Rockwood Frailty Score ≤ 3.\n* Serum bilirubin \\\u003C 30 µmol\u002FL.\n* Serum creatinine \\\u003C 150 µmol\u002FL.\n* Up to two lung metastases (\\\u003C 2cm in size permitted at enrolment).\n* Prior treatment with at least one course of systemic chemotherapy (± biologic agent) mandated. Chemotherapy protocol is not specified and is at clinician discretion.\n* Primary rectal tumour can remain in situ treated with radiotherapy\u002Fchemoradiotherapy according to tumour board recommendations. Primary colonic tumour can remain in situ.\n* No prior hepatic tumour ablation\n\nExclusion Criteria:\n\n* Patients involved in other research studies.\n* Inability to give informed consent.\n* Patients who are pregnant.\n* Accepted exclusions to IRE from consensus criteria including:\n* Platelet count \\\u003C 50x109 U\u002FL.\n* International normalised ratio (INR) for blood clotting \\> 1.7.\n* Prior hepatic tumour ablation.\n\nCardiovascular fitness related exclusions:\n\n* History of ventricular arrhythmia.\n* Implanted pacemaker or defibrillator.\n* Congestive cardiac failure NYHA Class ≥ 3.\n\nTumour-related exclusions:\n\n* Tumour ≥ 4 cm in size.\n* Advanced multi-site metastatic cancer (any of the following): peritoneal metastases (M1c), bone metastases, \\> 2 lung metastases, all segment involvement multiple liver metastases.\n* Jaundice (serum bilirubin \\> 30 µmol\u002FL).\n* MDT\u002Ftumour recommends use of thermal ablation instead of IRE for any given lesion.",{"count":105,"type":20},[23],"Procedural data will be recorded from patients with liver metastases from colorectal cancer who have received at least one course of systemic chemotherapy and who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation.",[150,151,152],"Colorectal Adenocarcinoma Metastatic in the Liver","Liver Ablation","Liver Cancer, Adult",[154,155,156,157,158],"irreversible electroporation","liver ablation","metastatic liver disease","nanoknife","liver ire registry","2025-10-08",{"date":161,"type":34},"2025-10-10",{"date":163,"type":20},"2026-02",{"date":165,"type":20},"2029-02",{"name":40,"class":41},1,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":177,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":184,"leadSponsor":185,"locationsCount":167},"100607759","international-study-on-treatment-of-liver-hcc-patients-with-ire-100607759","NCT07192731","International Study on Treatment of Liver (HCC) Patients With IRE","Treatment of LIVER-limited HepatoCellular Carcinoma (HCC) in Patients With Preserved Liver Function by IRreversible Electroporation: A Prospective, International, Multi-centre Cohort Study","LIVERHCC-IRE","Inclusion Criteria:\n\n* Patients aged 18 years and over, able to provide informed consent and with clinical diagnosis of an HCC. Tissue confirmation of HCC prior to treatment is not standard of care and is therefore not required for this study.\n* Child-Pugh A up to A6.\n* Eastern Co-operative Oncology Group (ECOG) Score ≤ 2.\n* Rockwood Frailty Score ≤ 3.\n* Serum bilirubin \\\u003C 30 µmol\u002FL.\n* Serum creatinine \\\u003C 150 µmol\u002FL.\n* No extrahepatic metastases\n* IRE can be used for up to 3 tumours \\\u003C 3cm in size. Other forms of ablation can be combined with IRE in the same sitting but not for the same lesion. IRE can also be combined with surgical resection.\n\nExclusion Criteria:\n\nGeneral:\n\n* Patients involved in other research studies.\n* Patients under the age of 18 years.\n* Inability to give informed consent.\n* Patients who are pregnant.\n* Child-Pugh B or C.\n* Patients with an ECOG status of \\> 2 at time of recruitment.\n* Rockwood Frailty Score \\> 3\n* Impaired renal function (serum creatinine \\> 150 µmol\u002FL)\n* Accepted exclusions to IRE from consensus criteria including:\n* Platelet count \\\u003C 50x109 U\u002FL.\n* International normalised ratio (INR) for blood clotting \\> 1.7.\n* Prior hepatic tumour ablation.\n\nCardiovascular fitness related exclusions:\n\n* History of ventricular arrhythmia.\n* Implanted pacemaker or defibrillator.\n* Congestive cardiac failure NYHA Class ≥ 3.\n\nTumour-related exclusions:\n\n* Tumour ≥ 3 cm in size.\n* Extrahepatic metastatic disease.\n* Jaundice (serum bilirubin \\> 30 µmol\u002FL).\n* MDT recommends use of thermal ablation for any given lesion.",{"count":105,"type":20},[23],"Procedural data will be recorded from patients with liver lesions from hepatocellular cancer who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation",[180,151,152],"Hepatocellular Carcinoma (HCC)",[154,155,157,158],{"date":161,"type":34},{"date":163,"type":20},{"date":165,"type":20},{"name":40,"class":41},{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":167},"100569674","evaluating-the-efficacy-safety-and-long-term-functional-outcomes-of-percutaneous-mechanical-aspiration-thrombectomy-for-treatment-of-acute-pulmonary-embolism-using-the-alphavac-multipurpose-mechanical-aspiration-mma-f1885-system-100569674","NCT06697314","Evaluating the Efficacy, Safety and Long Term Functional Outcomes of Percutaneous Mechanical Aspiration Thrombectomy for Treatment of Acute Pulmonary Embolism Using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System","Prospective, Multicenter, Multi-national, Single Arm Trial Evaluating the Efficacy, Safety and Long Term Functional Outcomes of Percutaneous Mechanical Aspiration Thrombectomy for Treatment of Acute Pulmonary Embolism Using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System","RECOVER-AV","Inclusion Criteria:\n\n* Symptomatic, CTPA-proven acute PE with a maximum duration of symptoms of 14 days, showing a filling defect in at least one main or proximal lobar pulmonary artery\n* RV\u002FLV diameter ratio ≥ 1.0 assessed by CTPA\n* Serum troponin levels above upper limit of normal as per hospital policy\n* ≥ 18 years of age\n* At least one of the following:\n\n  1. Electrocardiogram (ECG)-documented tachycardia with heart rate ≥ 100 BPM, not due to hypovolemia, arrhythmia or sepsis\n  2. Systolic blood pressure ≤ 110mmHg for at least 15 minutes\n  3. Respiratory rate \\> 20 breaths per minuted. Oxygen saturation on pulse oximetry (SpO2) \\\u003C 90% (or partial arterial oxygen pressure \\\u003C 60 mmHg) at rest while breathing room air\n  4. Known history of heart failure\n* Willing and able to provide written informed consent prior to receiving study specific procedures.\n\nExclusion Criteria:\n\n* A contraindication to therapeutic anticoagulation\n* Any comorbid diagnosis consistent with a life expectancy of less than 1 year (e.g., stage 4 cancer)\n* Known serious, uncontrolled sensitivity to radiographic agents\n* Cardiac arrest within last 14 days without documented evidence of recovery of conscious level to Glasgow Coma Scale \\>12\n* Indication for ECMO\n* Pregnant or breastfeeding\n* Participation in another investigational drug or device study that study may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.\n* Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow- up requirements, or that could impact the scientific integrity of the study.\n* History of congenital or acquired bleeding disorder predisposing to hemorrhagic state\n* Platelet count \\\u003C 100,000\u002FμL\n* Any advanced reperfusion therapy for pulmonary embolism within 30 days of the index procedure (e.g lysis, surgery, catheter intervention)\n* A known clot in transit\n* IVC filter\n* A do not resuscitate limitation at inclusion in the study\n* Deprived of liberty or under court protection",{"count":195,"type":20},256,[23],"To evaluate the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute pulmonary embolism.",[199,200],"Acute Pulmonary Embolism (PE)","Pulmonary Embolism","2025-09-23",{"date":203,"type":34},"2025-09-26",{"date":205,"type":34},"2025-06-15",{"date":207,"type":20},"2028-06",{"name":40,"class":41},""]