[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"device-safety\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:device-safety":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100341763","restoring-flow-by-revascularization-with-submaximal-angioplasty-in-hemodynamic-intracranial-atherosclerotic-stenosis-100341763",false,"NCT03729817","REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis","VERiTAS-2 REFRESH ICAS (REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis)","Inclusion:\n\n* Non-severe recent stroke (within 30 days) attributed to 70-99% stenosis of intracranial artery (internal carotid, middle cerebral, vertebral, basilar); must be confirmed by CTA (or DSA if already available) for enrollment into the trial.\n* Hemodynamic compromise based on borderzone infarct pattern\\* for the anterior circulation (internal carotid and middle cerebral artery stenosis) and by low flow state on QMRA\\*\\* for the posterior circulation (vertebral and basilar artery stenosis).\n* Target vessel with minimal nominal diameter of 2mm\n* Target length of stenosis \\\u003C18mm\n* Symptoms within 30 days of enrollment\n* Age ≥30 and ≤90 years old#\n* Able to provide informed consent\n\n  * \\*Sole or predominant borderzone infarct pattern of qualifying event, as defined by SAMMPRIS cohort analysis \\*\\*Low flow state as determined by optimized flow algorithm as defined by the VERiTAS Study\n  * #Those 30-49 years of age must also have the presence of established atherosclerotic disease in another vascular bed (coronary, extracranial carotid, peripheral) or the presence of 2 or more risk factors (hypertension, diabetes mellitus, hyperlipidemia, tobacco abuse within the last 2 years).\n\nExclusion:\n\n* Major disabling stroke mRS \\>3; progressive or fluctuating deficit within 24 hours\n* Hemorrhagic infarction (based on CT) within 14 days of enrollment\n* Any large stroke (\\>5cm) to be at risk for hemorrhagic conversion\n* Any neurological disease which would confound follow-up assessment\n* Any co-morbid disease condition with \\\u003C12 month life expectancy\n* Known cardiac disease associated with elevated cardioembolic risk, specifically, atrial fibrillation, prosthetic valve, endocarditis, left atrial\u002Fventricular thrombus, cardiomyopathy with EF\\\u003C25%, cardiac myxoma\n* Blood dyscrasias, specifically polycythemia vera, essential thrombocytosis, sickle cell disease\n* Active bleeding diathesis, h\u002Fo major systemic hemorrhage within 30 days, active PUD, platelets\\\u003C100K (severe liver impairment (AST or ALT\\>3 x normal, cirrhosis)\n* Non-atherosclerotic stenosis including dissection, fibromuscular dysplasia, vasculitis, radiation induced vasculopathy, suspected recanalized embolus, suspected vasospastic process\n* Mori C classification of stenosis (i.e. diffuse lesion, extremely angulated \\>90⁰, excessive proximal tortuosity) Previous treatment of target lesion with stent, angioplasty or other mechanical device\n* Extracranial vertebral artery or carotid artery tortuosity, stenosis or occlusion prohibiting access to the target lesion (not exclusionary if does not prohibit access to target lesion)\n* Unable or unwilling to undergo MRI\n* Unable to undergo cerebral angiography\n* Pregnancy\n* Concurrent participation in another study which would conflict with the current study\n* Allergy or contraindication to aspirin or Plavix\n* Indication for warfarin or NOAC beyond enrollment (e.g. venous thrombo-embolism, atrial fibrillation)\n* Thrombolytic therapy within 24 hours","ALL","30 Years","90 Years",{"count":20,"type":21},159,"ESTIMATED","INTERVENTIONAL",[24],"NA","By assessing the safety and durability of an endovascular intervention, this study will justify and inform the design of a subsequent seamless feasibility\u002Fpivotal trial aimed at the treatment of intracranial atherosclerotic stenosis (ICAS), an entity which carries a high risk of stroke despite existing medical therapies, and has no other treatment options. Given the global burden of ICAS as a leading cause of stroke, there is a high potential for public health impact not just in the U.S., but world-wide.",[27,28,29,30,31],"Intracranial Atherosclerotic Disease","Stroke","Angioplasty, Balloon","Hemodynamics","Device Safety",[33,28,29,30,31],"Intracranial atherosclerotic disease","NOT_YET_RECRUITING","2025-11-03",{"date":37,"type":38},"2025-11-04","ACTUAL",{"date":40,"type":21},"2027-10",{"date":42,"type":21},"2032-10-31",{"name":44,"class":45},"Case Western Reserve University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":46},"100603322","adaptive-study-to-assess-the-safety-and-functioning-of-motiva-devices-on-minimally-invasive-gluteal-augmentation-100603322","NCT07135011","Adaptive Study to Assess the Safety and Functioning of Motiva Devices on Minimally Invasive Gluteal Augmentation","Adaptive Study to Assess the Initial Safety and Functioning of the Minimally Invasive Gluteal Augmentation Procedure and Its Devices in Participants Undergoing Primary Gluteal Enhancement","GEM","Inclusion Criteria:\n\n* Cisgender women, aged 18 years or older.\n* Participants without prior buttock augmentation or biopolymer injections in the buttocks.\n* Participants classified as ASA class I and II according to the American Society of Anesthesiologists (ASA) classification system for estimating risk.\n* Participants seeking buttock enhancement, aiming to simply restore the aesthetic curvature of the back.\n* Body mass index between 18.5 and 28.\n* Adequate tissue available to cover the implant(s).\n* Willingness to comply with all study requirements and agree to attend all required follow-up visits.\n* Agreement to return the device to the sponsor in case of explantation.\n\nExclusion Criteria:\n\n* Women with massive weight loss.\n* Buttock ptosis or poor skin quality.\n* Inadequate tissue (e.g., due to radiation damage, ulceration, compromised vascularization, history of compromised healing).\n* Current pregnancy.\n* History of abscesses or infections in the buttock area.\n* History of sensitivity to silicone.\n* Any medical condition such as underweight or obesity according to inclusion criteria, diabetes, autoimmune disease, or severe chronic pulmonary or cardiovascular disease resulting in excessively high surgical risk and significant postoperative complications.\n* History of psychological characteristics that are unrealistic or unreasonable given the risks associated with the surgical procedure.\n* Use of any medication that, according to the investigator's experience, may pose a higher risk of complications or interfere with wound healing capacity, such as corticosteroid treatment or blood-thinning medications (e.g., concomitant treatment with warfarin).\n* Participants who do not reside in the Great Metropolitan Area of Costa Rica, which makes it difficult for them to attend follow-up visits.",true,"FEMALE","18 Years",{"count":59,"type":21},120,[24],"The objective of this clinical trial is to assess the initial performance and safety of Motiva® Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator utilized in a minimally invasive gluteal augmentation procedure, involving 120 healthy female participants.\n\nThe main questions it aims to answer are:\n\n* Are the main side effects and complications experienced by participants who underwent a minimally invasive buttock enhancement procedure with Motiva Ergonomix2® Diamond®, the Motiva Injector®, the Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator adequately characterized?\n* Can the Motiva Injector®, Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator be successfully utilized, and are any failures in the process detected?\n* Does the Motiva® GEM Channel Separator effectively perform tissue dissection procedures without experiencing operational dysfunctions?\n* Are both the surgeon and the participant satisfied with the procedure outcomes?\n* Is the proper functioning of the Zen microtransponder verified? Participants will undergo a minimally invasive buttock enhancement procedure using the Ergonomix2® Diamond®, the Motiva Injector®, the Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator, and have a follow-up of 24 months to see the results.",[31],[64,65],"Equipment safety","Buttock augmentation","RECRUITING","2025-08-20",{"date":69,"type":38},"2025-08-21",{"date":71,"type":38},"2023-04-12",{"date":73,"type":21},"2026-04",{"name":75,"class":76},"Establishment Labs","INDUSTRY",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":57,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100565646","complications-of-the-cephalic-route-in-implantable-site-placement-in-children-100565646","NCT06644885","Complications of the Cephalic Route in Implantable Site Placement in Children","SitePedia","Inclusion Criteria:\n\n* All patients under 18 years who underwent TIVAD implantation between 2012 and 2022.\n* Patients for whom cephalic vein cutdown was the first attempted surgical technique for device placement.\n\nExclusion Criteria:\n\n* Patients who previously had a central venous access",{"count":85,"type":21},426,"OBSERVATIONAL","Totally implantable venous access devices (TIVADs) offer long-term central venous access for children requiring intravenous treatments. Their use is recommended in infants (31 days - 1 year old) for \\>31 days of non-peripherally compatible therapy, and in children and adolescents (\\>1 year old) for any intravenous therapy lasting more than 31 days. Indications include chemotherapy administration and chronic disease management, avoiding repeated peripheral venous punctures and causing less interference with the activities of the patients.\n\nThere are several methods for TIVAD placement, but the optimal evidence-based method remains unclear . The two main approaches for TIVAD placement are closed cannulation of a vein, followed by insertion of the catheter in Seldinger technique, and the surgical insertion of the catheter into a vein through an open cut-down technique 5-7. Different location of insertion are possible: by closed cannulation, the catheter is usually placed in subclavian vein, internal jugular vein, and brachiocephalic vein; by open cut-down it can be placed in external jugular vein, axillary vein, or cephalic vein.\n\nThanks to progress in medical and surgical care, children are nowadays surviving previously fatal illnesses, but with the need of long-term treatments. For this reason, it's essential to preserve their vessel health. With this objective, in the CHU of Angers, physicians prefer trying first the cephalic vein cutdown for TIVAD positioning in children, reserving the use of other venous accesses in case of failure of this procedure or the need for multiple devices implantations.\n\nTo date, few reports have been published about cephalic vein cutdown in children. It is a common opinion that this technique can't be successfully performed in patients under a certain limit of weight or age. In this context, the investigators conducted a retrospective single-centre study to analyse the results of cephalic vein cutdown in children. The primary aim was to describe the feasibility of this technique in paediatric population and identify the risks factors associated with its failure. In addition, this study describes indications, outcomes, and complications of TIVAD implantation.",[89,31],"Surgical Complications","2024-10-14",{"date":92,"type":38},"2024-10-16",{"date":94,"type":21},"2024-12-15",{"date":96,"type":21},"2025-04-15",{"name":98,"class":99},"University Hospital, Angers","OTHER_GOV"]