[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tau Medical Australia Pty Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"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":42},"100602342","early-feasibility-study-efs-of-the-carol-for-treatment-of-lung-cancer-stage-1-100602342",false,"NCT07122258","Early Feasibility Study (EFS) of the 'CAROL' for Treatment of Lung Cancer Stage 1","To Investigate the Safety of the CAROL Device for Lung Tumour Treatment in Patients With Non-small Cell Lung Cancer Tumours(s) ≤ 2 cm (cT1b)","Inclusion Criteria:\n\nThose who meet all the following criteria are eligible to participate in the clinical trial.\n\n1. Adults 18 years of age or older at the time of screening\n2. NSCLC tumour(s)≤ 2 cm (cT1b) suitable for resection\n3. Suitable candidate for resection per standard of practice (Lobectomy)\n4. NSCLC is confirmed pathologically for the tissue that will be ablated\n5. Location of tumour:\n\n   * ① in outer one thirds of lung (between outermost 1\u002F3 measured by tumour centre),\n   * ② if the centre of the tumour is located within the outermost 1\u002F3, inclusion will proceed,\n   * ③ anticipation that resection (lobectomy) would remove all gross tumour and ablation with grossly negative margins,\n   * ④ one or more radiofrequency ablation (RFA) applications would target entire margin according to the RFA plan\n6. Signed free and informed consent as prescribed by hospital policies.\n\nExclusion Criteria:\n\nThose who meet any of the following criteria are excluded from this clinical trial.\n\n1. Centralised tumour (inner most one third) not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, oesophagus or trachea)\n2. Other primary lung tumours\n3. Tumour is associated with vulnerable zone of pleural effusion\n4. If the centre of the tumour is not located within the outermost 1\u002F3, exclusion will proceed\n5. PFT: post-bronchodilator forced expired volume in on second (FEV1) or forced vital capacity (FVC) ≤60% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 50% predicted\n6. Patients with evidence of severe chronic pulmonary disease including asthma, Chronic Obstructive Pulmonary Disease (COPD), or Interstitial Lung Disease (ILD).\n7. Requirement of supplemental oxygen at rest or exercise\n8. Hospitalization for cardiac disease within the preceding 3 months\n9. Liver enzymes (Alanine Aminotransferase \\[ALT\\], Alkaline Phosphatase \\[ALP\\], Aspartate Aminotransferase \\[AST\\]) or total bilirubin \\>1.5 upper limit of normal (ULN)\n10. Serum creatinine \\> 2 mg\u002Fdl\n11. Recent infection (within 30 days)\n12. Receiving immunosuppressive medication or prednisone \\> 20 mg\u002Fday (or equivalent)\n13. Pre-existing implants - either within the airways or any other location - that impede navigation to or visualisation of the target lesion, in the opinion of the investigator\n14. Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.\n15. Disorder of coagulation, history of severe haemoptysis, or receiving anticoagulant medication. Antiplatelet medication is permitted provided that the medication can be held a minimum of 7 days prior to the procedures and 10 days post-procedures, where this refers to both the ablation and surgical procedures\n16. Any condition or anatomical factor that, in the opinion of the investigator or reviewer, may interfere with the safety of the patient, the conduct of the procedure, or evaluation of the study objectives (e.g. severe bronchial narrowing, wall compromise)\n17. Any tumour characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives\n18. Contraindication to complete neuromuscular blockade during the ablation procedure\n19. Implantable cardiac devices such as pacemakers or defibrillators, especially with unipolar electrode configurations\n20. Known hypersensitivity or allergy to gallium, indium, or other components of the conformable electrode\n21. Medically inoperable conditions\n22. Participant who is currently participating in, or planning to participate in (during the course of the trial), another non-observational clinical research study\n23. Participants who have participated in a non-observational clinical research study within either the past 30 days or who are still within the intervention's wash-out period (whichever is longer)\n24. Participant who, in the opinion of the investigator, is not suitable for participation in the study","ALL","18 Years",{"count":19,"type":20},7,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study aims to evaluate the safety of the CAROL device for treating lung tumors in patients diagnosed with non-small cell lung cancer (NSCLC) with tumor size ≤ 2 cm (cT1b). The primary objective is to assess safety by monitoring and grading adverse events using the CTCAE v5.0 criteria at one month following the procedure.",[26],"NSCLC (Non-small Cell Lung Cancer)",[28,29],"CAROL","TAU MEDICAL","RECRUITING","2026-03-03",{"date":33,"type":34},"2026-03-05","ACTUAL",{"date":36,"type":20},"2026-03-01",{"date":38,"type":20},"2027-06-01",{"name":40,"class":41},"Tau Medical Australia Pty Ltd","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100606201","early-phase-study-using-the-pivot-extend-system-as-a-treatment-for-patients-with-tricuspid-regurgitation-100606201","NCT07172477","Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation","Early Feasibility Study (EFS) of the 'Pivot Extend' for the Treatment of Tricuspid Regurgitation, Including High-Risk Patients (SPACER Study, Australia)","SPACER","Inclusion Criteria:\n\n* Has voluntarily decided to participate in this clinical trial and has provided written informed consent\n* Adults aged 18 years or older at the time of informed consent\n* Has symptoms of TR corresponding to at least NYHA Class II, despite receiving optimal medical therapy for at least 30 days prior to screening\n* Meets the criteria at least severe (3+) on the TR grade classification table on echocardiography performed at the screening visit\n* Deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist and one cardiac surgeon\n* Is able to understand and follow the investigator's instructions and is able to participate for the entire duration of the study\n\nExclusion Criteria:\n\n* Has blood clots, emboli, masses, or growths in the vascular system of the heart or lungs on an echocardiogram and cardiac CT scan performed at the screening visit\n* Uncorrected blood clotting disorders based on hematology tests performed at the screening visit\n* Unable to use anticoagulant agents (NOAC ex.Xarelto)\n* A history of major bleeding (excluding minor bleeding such as nosebleed that can be hemostasized) treated with anticoagulants at any time prior to participation in this clinical trial\n* Severe anemia (hemoglobin less than or equal to 80g\u002FL)\n* Has an implanted device such as an implantable cardioverter defibrillator (ICD) or pacemaker\n* Has anatomy that, in the opinion of the investigator, is not suitable for implantation of an investigational medical device based on echocardiogram and cardiac CT scan performed at the screening visit\n* Requires surgery or interventional procedures (coronary artery bypass graft (CABG) or surgery for atrial septal defect (ASD)) based on an echocardiogram performed at the screening visit\n* Platelet count of 50 x 10\\^9 per litre of blood or less based on hematology tests performed at the screening visit\n* Pulmonary arterial hypertension, defined as pulmonary artery systolic pressure greater than 70mmHg on cardiac catheterization performed at the screening visit, or a pulmonary vascular resistance greater than 3 Wood Units on right heart catheterization\n* Left ventricular ejection fraction (LVEF) of less than 20% on echocardiogram performed at the screening visit\n* Active gastrointestinal bleeding or a digestive procedure within 90 days prior to screening for this study, and\u002For those with the potential for gastrointestinal bleeding in the opinion of the investigator\n* History of cerebrovascular accident (CVA) or transient ischemic attacks (TIA) within 30 days prior to screening for this clinical trial\n* History of myocardial infarction (MI) within 30 days prior to screening for this study\n* Active endocarditis requiring antibiotic treatment\n* Malignancies or end-stage renal failure requiring hemodialysis and other chronic conditions with a life expectancy of less than one year\n* Moderate or severe aortic, pulmonary artery, or mitral stenosis on echocardiogram performed at the screening visit\n* Severe or greater mitral valve regurgitation or severe aortic valve regurgitation as determined by echocardiographic grading criteria at the screening visit\n* Calcification of the tricuspid valve leaflets affecting the procedure on an echocardiogram performed at the screening visit\n* Those who have participated in another clinical trial within 30 days prior to screening for this clinical trial\n* Pregnant or breastfeeding, or planning to become pregnant during the clinical trial period\n* Participants of childbearing potential who are not using a highly effective method of contraception\n* Coexisting condition, which most likely limits the life expectancy to less than one year\n* Preexisting pulmonary valve prosthesis or a right ventricle to pulmonary artery (RV-PA) conduit\n* Any other clinical findings that, in the opinion of the investigator, are medically inappropriate for this clinical trial",{"count":52,"type":20},10,[23],"Participants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients or those with other medical conditions.\n\nThe goal of this clinical investigation is\n\n* To assess the safety of the investigational device \"Pivot Extend\" in participants aged 18 years or over with severe and clinically symptomatic Tricuspid Regurgitation (TR) deemed suitable for percutaneous valve intervention\n* To evaluate device success, procedural success and clinical outcomes in improving TR symptoms following implantation of the \"Pivot Extend\" device",[56],"Tricuspid Regurgitation",[56,49,58],"Pivot Extend","2025-12-02",{"date":61,"type":34},"2025-12-09",{"date":63,"type":34},"2025-11-11",{"date":65,"type":20},"2027-03",{"name":40,"class":41},""]