[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Arsenal Medical, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100634570","mma-embolization-with-neocast-for-subacute-and-chronic-subdural-hematoma-100634570",false,"NCT07541404","MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma","Pivotal Study of the Treatment of Symptomatic Subacute and Chronic Subdural Hematoma Via Middle Meningeal Artery Embolization With the NeoCastTM Embolic System (RADIANT)","RADIANT","Inclusion Criteria:\n\n* Participant whose age is ≥ 18 and ≤ 90 years;\n* Pre-morbid mRS ≤ 2;\n* Confirmed diagnosis of subacute or chronic subdural hematoma that measures ≥10 mm in greatest thickness;\n* Participant presents with one or more of the following corroborating neurological symptoms: headache; cognitive decline; speech difficulty; gait impairment or imbalance; focal neurological deficit; and\u002For seizure, within the last 30 days;\n* Participant is planned for middle meningeal artery embolization within ±7 days of surgical evacuation of hematoma via burr hole or craniotomy;\n* Participant or Legally Authorized Representative\u002FPerson Responsible for consenting on their behalf understands the nature of the procedure, consents to participation in the study and provides a signed informed consent form;\n* Participant (woman of child-bearing potential) with a current negative pregnancy test who has agreed to an appropriate method of contraception throughout the trial;\n* Participant is willing to return to the investigational site for follow-up visits.\n\nExclusion Criteria:\n\n* Diagnosed with acute SDH\n* Participant with prior embolization of either MMA\n* Participant with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed\n* Participant with bilateral SDH where both sides require surgery or contralateral SDH \\>5mm in greatest thickness\n* Participant identified with potentially dangerous anatomic variations leading to increased procedural risk, risk of incomplete embolization, or unsafe access for MMA embolization (i.e., MMA originating from ophthalmic artery)\n* Participant who presents with a meningioma ≥1 cm or \\\u003C 1 cm with mass effect\n* Subjects with conditions placing them at high-risk for ischemic stroke who cannot be taken off anticoagulants for at least 7 days post-surgery\n* Participant currently undergoing radiation therapy for carcinoma or sarcomas of the head or neck region\n* SDH developed due to underlying condition or structure pathology (e.g., dural AV fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt, spontaneous intracranial hypotension or previous craniotomy)\n* Presumed microbial superinfection\n* Participant who is breastfeeding\n* Participant with life expectancy of \\\u003C1 year\n* Participants with acute renal impairment that the investigator assesses could be at risk for contrast induced nephropathy\n* Participant with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically)\n* Participant is allergic to any of the materials used in the NeoCast device or the Onyx LES commercial embolic device\n* Participant who is currently participating or planning to participate within 6 months in another clinical research study","ALL","18 Years","90 Years",{"count":21,"type":22},360,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the NeoCast Embolic System for treatment of symptomatic subacute or chronic subdural hematoma (SDH) adjunctive to surgery.",[28],"Subdural Hematoma",[30,31,32,33,34],"Hematoma","Chronic subdural hematoma (cSDH)","Subacute subdural hematoma","Subdural hematoma (SDH)","Middle Meningeal Artery (MMA) Embolization","NOT_YET_RECRUITING","2026-05-18",{"date":38,"type":39},"2026-05-20","ACTUAL",{"date":41,"type":22},"2026-07",{"date":43,"type":22},"2028-04",{"name":45,"class":46},"Arsenal Medical, Inc.","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100276581","revive-reducing-exsanguination-via-in-vivo-expandable-foam-100276581","NCT02880163","REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam","Reducing Exsanguination Via In-Vivo Expandable Foam","REVIVE","Inclusion Criteria:\n\n1. Estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown)\n2. Emergent, exsanguinating hemorrhage, from abdominal source as defined by:\n\n   * Class III or IV hemorrhagic shock or\n   * Assessment of Blood Consumption (ABC) score ≥ 2\n3. Confirmation of abdominal hemorrhage by:\n\n   * Direct visualization or\n   * Positive Focused Assessment with Sonography in Trauma (FAST) or\n   * Diagnostic Peritoneal Aspiration (DPA)\n4. No other known, uncontrolled active sources of hemorrhage\n5. Subject is intubated and sedated per local guidelines\n6. Decision to administer foam is made within 30 minutes of admission to the emergency department.\n7. Decision made to proceed to emergent laparotomy made within 30 minutes of admission to the emergency department.\n8. Definitive surgical care is expected to occur within three hours of foam deployment\n9. Subject must also be receiving concurrent transfusion of fluids or blood products.\n\n   Exclusion Criteria:\n10. Known or suspected major diaphragm injury\n11. Known or suspected untreated pneumothorax\n12. Known or suspected untreated hemothorax\n13. Known or suspected blunt or penetrating cardiac or thoracic aortic trauma\n14. Traumatic brain injury resulting in decapitation, visible brain matter or considered non- survivable based on initial physical exam\n15. Received greater than five consecutive minutes of cardiopulmonary resuscitation in the pre-emergency department setting\n16. Patients with Pulseless Electrical Activity\n17. Known allergy to isocyanate\n18. Known or suspected pregnancy\n19. History of prior abdominal surgery or evidence of abdominal surgery (scars)\n20. Disrupted abdominal wall that, in the opinion of the investigator would preclude ResQFoam from being adequately contained within the abdominal cavity\n21. Subject in whom the abdominal aortic junctional tourniquet (AAJT) or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) techniques have been used\n22. Known Prisoners\n23. Subjects with burns \\> 20% of total body surface area\n24. Subject\u002Flegally authorized representative\u002Fsubject family member purposefully opted out of participation in the study\n25. Known Do Not Resuscitate order (DNR) or Physician Orders for Life Sustaining Treatment (POLST)\n26. Known enrollment in another randomized, interventional study","15 Years",{"count":57,"type":22},40,[25],"The purpose of this study is to demonstrate safety, effectiveness and benefit-risk profile of ResQFoam for the inhospital treatment of exsanguinating, intraabdominal haemorrhage due to trauma in patients where emergent laparotomy is required.",[61,62,63,64],"Hemorrhagic Shock","Trauma","Exsanguinating Hemorrhage","Shock; Traumatic","RECRUITING","2025-11-07",{"date":68,"type":39},"2025-11-10",{"date":70,"type":39},"2025-08-07",{"date":72,"type":22},"2026-12-31",{"name":45,"class":46},""]