[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"craniotomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:craniotomy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,48,84,106,133,158,181,214],{"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":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100571990","an-analgesia-first-strategy-without-hypnotic-sedatives-in-adult-patients-admitted-to-the-intensive-care-unit-after-neurosurgical-craniotomy-100571990",false,"NCT06727435","an Analgesia-first Strategy Without Hypnotic Sedatives in Adult Patients Admitted to the Intensive Care Unit After Neurosurgical Craniotomy","Feasibility and Safety of an Analgesia-first Strategy Without Hypnotic Sedatives in Adult Patients Admitted to the Intensive Care Unit After Neurosurgical Craniotomy: a Single-arm, Single-centre Exploratory Prospective Study","Inclusion criteria\n\n1. Age 18-85 years;\n2. Admission to the ICU after neurosurgical craniotomy;\n3. Anticipated ICU stay greater than 24 hours according to the treating team at ICU admission or screening;\n4. The Richmond Agitation-Sedation Scale (RASS) score ≥ +1, indicating restlessness or agitation requiring clinical management;\n5. RASS, the Critical Care Pain Observation Tool (CPOT), and neurological status can be assessed reliably enough for protocol monitoring.\n\nExclusion criteria\n\n1. Need for deep sedation or therapeutic coma, including (partial pressure of oxygen(PaO2)\u002Ffraction of inspired oxygen(FiO2): PaO2\u002FFiO2≤100 mmHg, neuromuscular blockade requiring unconsciousness, status epilepticus, mandatory immobility for surgical or procedural safety, severe traumatic brain injury and intracranial hypertension, therapeutic hypothermia and any clinical condition requiring RASS \\\u003C -2) \\[15, 16\\];\n2. Medullary lesion, brainstem condition, or other disorder associated with impaired respiratory drive in which opioid analgesia is judged unsafe by the treating physician \\[17\\];\n3. Inability to assess the RASS score or neurological status because of coma, severe aphasia, status epilepticus, severe cognitive dysfunction, schizophrenia, mania, or aother psychiatric or neurological condition that precludes reliable assessment.;\n4. Use of sedatives or opioid analgesics ≥ 1 week before enrollment;\n5. Expected ICU stay time less than or equal to 24 hours;\n6. Delirium, alcohol withdrawal, active severe psychiatric illness, or ongoing antipsychotic therapy before enrolment;\n7. Severe hepatic dysfunction (Child-Pugh grade C);\n8. Renal failure requiring renal replacement therapy;\n9. Need for major surgery during the ICU stay, except short bedside or minor procedures, such as lumbar puncture or ventricular drainage, etc.);\n10. Known allergy or contraindication to remifentanil, morphine, midazolam, propofol, or other protocol medications;\n11. Pregnancy or lactation;\n12. Participation in another interventional clinical trial that could interfere with the study intervention or outcomes.;\n13. Patient or legally authorized representative unwilling to participate;\n14. Investigator judgment that inclusion is inappropriate because of a specific safety concern that is documented in the screening record.","ALL","18 Years","85 Years",{"count":20,"type":21},65,"ESTIMATED","INTERVENTIONAL",[24],"NA","Analgesia and sedation are core components of intensive care unit (ICU) care. They are used to relieve pain and anxiety, prevent harmful physiological stress responses, improve tolerance of invasive devices and mechanical ventilation, and reduce noxious stimulation. Contemporary ICU practice has moved away from deep continuous sedation toward analgesia-first care, lighter sedation targets, delirium prevention, early mobilization, and patient-centred comfort strategies.\n\nPatients admitted to the ICU after neurosurgical craniotomy pose a specific challenge. Postoperative agitation after intracranial surgery may lead to unplanned extubation, catheter or drain removal, injury, hypertension, coughing, increased sympathetic activation, and potentially adverse neurological consequences. The incidence of agitation after elective intracranial operations was 29%, which was higher than that previously observed in other surgical populations. Neurosurgical patients may be more vulnerable to stress caused by agitation, due to longer anesthesia duration, delayed extubation and pain and post-craniotomy frontal pneumocephalus. Brain lesions and intracranial manipulations in neurosurgical patients might affect the brain regions which involves cognition and emotion, and are assumed to influence postoperative cognition. At the same time, excessive hypnotic sedation may obscure level of consciousness, pupillary and focal neurological examinations, early seizures, intracranial hypertension, or surgical complications. Previous neurosurgical studies have reported postoperative agitation and delirium after craniotomy were not rare, and risk factors including longer anesthesia duration, delayed extubation, pain, and postoperative pneumocephalus have been reported.\n\nHowever, the investigations of analgesia and sedation in neurosurgical populations have been inadequate. Most of the researches about analgesia and sedation in general ICU were excluded the neurosurgical patients. These patients are special for its cruciality of evaluating the consciousness and neurological signs examination. The analgesia and sedation management is difficult and complex. Several general ICU studies support interest in minimizing routine hypnotic sedation. In a single-centre randomized trial, a protocol of no sedation with morphine boluses increased ventilator-free days and shortened ICU and hospital stay compared with sedation and daily interruption, although agitated delirium was more frequent. In the larger multicentre NONSEDA trial, mortality at 90 days did not differ significantly between nonsedation and light sedation with daily interruption, and many patients in the nonsedation group still required sedatives during ICU stay, most commonly because of delirium. Related NONSEDA substudies have also emphasized that the effects of nonsedation on physical function and cognition require dedicated evaluation.\n\nThese findings cannot be directly transferred to post-craniotomy neurocritical care. Reviews, consensus statements and observational studies in neurocritical care emphasize with brain-injured patients have unique sedation indications, including control of intracranial pressure, seizures, cerebral oxygen consumption, ventilator synchrony, and severe agitation. Observational data from brain-injury ICUs show wide variation in sedative and analgesic practice and support structured use of sedation and pain scales. Expert consensus also supports administering analgesics before sedatives when clinically appropriate, but acknowledges the limited high-quality evidence in this population. Therefore, an analgesia-first strategy without routine hypnotic sedatives should be evaluated cautiously with explicit neurological safety monitoring and rescue criteria.\n\nRemifentanil is a short-acting opioid with rapid onset and offset because it is metabolized by non-specific blood and tissue esterases. These pharmacological features make it suitable for titrated analgesia when repeated neurological assessment is needed. We therefore designed this single-arm exploratory study to estimate the feasibility and safety of a remifentanil-based analgesia-first strategy without routine hypnotic sedatives in selected adult patients admitted to ICU after neurosurgical craniotomy.",[27,28],"Craniotomy","Neurosurgical Patients",[30,31,32,33,34],"neurosurgical patients","analgesia-first","remifentanil","analgesia and sedation","neurosurgical craniotomy","NOT_YET_RECRUITING","2026-05-23",{"date":38,"type":39},"2026-05-28","ACTUAL",{"date":41,"type":21},"2026-08-01",{"date":43,"type":21},"2028-08-31",{"name":45,"class":46},"Beijing Tiantan Hospital","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":68,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":47},"100624596","analysis-of-cerebrospinal-fluid-leakage-after-surgery-for-intracranial-tumors-100624596","NCT07411690","Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors","Cerebrospinal Fluid Leak Incidence, Management and Risk Factor After Supratentorial Craniotomy for Intracranial Tumors: a Prospective Observational Study.","CSF-IMR","Inclusion Criteria:\n\n* Male or female at least 18 years old\n* Qualified for a craniotomy due to supratentorial intracranial tumor\n\nExclusion Criteria:\n\n* Revision surgery due to recurrent brain tumor\n* Emergency neurosurgical procedure",{"count":57,"type":21},200,"6 Weeks","OBSERVATIONAL","Cerebrospinal fluid is a clear fluid that surrounds and protects the brain. During surgery for brain tumors, neurosurgeons often need to open the covering of the brain (the dura) to reach the tumor. At the end of the operation, this covering is carefully closed again. In some cases, the closure might not be completely adequate leading to cerebrospinal fluid leak. This leakage may collect under the scalp or flow out through the surgical wound. When this happens, the surgical wound may not heal properly, and the risk of infection can increase. These complications can delay recovery and may postpone additional treatments, such as radiotherapy or chemotherapy, that are often needed after brain tumor surgery. Although cerebrospinal fluid leakage is less common after supratentorial craniotomy (surgery on the upper part of the brain) than after other types of brain surgery, it remains a challenging complication and has not been well studied in this group of patients. The aim of this study is to determine how often cerebrospinal fluid leakage occurs after supratentorial craniotomy for intracranial tumors, identify factors that increase the risk of leakage, and evaluate how these leaks are managed. Understanding these factors may help reduce the occurrence of cerebrospinal fluid leakage and improve postoperative recovery in the future.",[62,63,64,27,65,66,67],"Brain Tumor Adult","Brain Tumor Benign","CerebroSpinal Fluid (CSF) Leak","Glioblastoma","Glioma","Meningioma",[69,70,71,72,73],"intracranial tumor","cerebrospinal fluid leak","supratentorial craniotomy","glioma","meningioma","RECRUITING","2026-05-19",{"date":77,"type":39},"2026-05-22",{"date":79,"type":39},"2026-02-03",{"date":81,"type":21},"2028-04",{"name":83,"class":46},"Medical University of Warsaw",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100627739","safety-and-effectiveness-of-tetranite-bone-adhesive-for-cranial-flap-fixation-compared-to-traditional-metal-hardware-100627739","NCT07452549","Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware","Inclusion Criteria:\n\n* Subject, and\u002For subject's family are able and willing to provide informed consent and HIPAA authorization prior to any study related procedures.\n\n  * Subjects can be any gender, but be between (and including) 18 and 80 years of age\n  * Subject is scheduled for a cranial procedure that requires the creation of a bone flap or replacement of a bone flap (i.e., cranioplasty)\n  * Subject is scheduled for a cranial procedure in the supratentorial location.\n  * Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.\n  * Pre-operative CT scan for craniotomy patients must be less than or equal to 0.625 mm slice thickness and pixel spacing. It shall include the skull in native condition near the planned flap site DICOM export must be thin sliced reconstruction in the bone window.\n\nIntra-Operative Inclusion Criteria:\n\n• Width of craniotomy kerf line \\\u003C 3mm for more than 75% of the bone flap border.\n\nExclusion Criteria:\n\n* Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy is not exclusionary).\n\n  * Subject requires a craniectomy (the bone flap is not replaced during the current surgery).\n  * Subject has had radiation treatment to the surgical site within the past year, or standard fractionated radiation therapy was planned within 2 weeks post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure was not an exclusion criterion.)\n  * Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells were appropriately sealed (e.g., bone wax).\n  * Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics. Subject has undergone chemotherapy treatment, excluding hormonal therapy, within three weeks prior to the planned index procedure, or use of intracavitary chemotherapy wafer (BCNU) was planned, or chemotherapy treatment was planned within two weeks after the index procedure was performed.\n  * Standard use of peri-operative steroids (i.e., corticosteroids) is permitted. Chronic steroid use (defined as daily use of corticosteroids for ≥ 8 weeks) for the purposes of reducing the side effects of chemotherapy and\u002For radiation therapy for cancer is not exclusionary unless the patient is deemed by the investigator to be suffering from steroid toxicity (i.e., Cushing's syndrome) manifested by symptoms and signs such as thin skin, striae, easy bruising, muscle atrophy, upper body obesity, severe fatigue, etc. Use of corticosteroids on a chronic basis (as defined previously) for purposes other than decreasing the symptoms of systemic chemotherapy is exclusionary unless those steroids were discontinued 4 weeks prior to the planned index procedure.\n  * Subject has a condition with anticipated survival shorter than one year.\n  * Subject receives warfarin, heparin, other anticoagulant agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.\n  * Subject is pregnant, breast-feeding, or intended to become pregnant during the course of the study.\n  * Current infection (either superficial or deep) at the planned operative site\n  * Sepsis diagnosed within one week before the planned index procedure","80 Years",{"count":92,"type":21},204,[24],"The aim of this study is to demonstrate the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware.",[27],"2026-03-02",{"date":98,"type":39},"2026-03-05",{"date":100,"type":21},"2026-04-15",{"date":102,"type":21},"2027-12-15",{"name":104,"class":105},"RevBio","INDUSTRY",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":16,"minAge":17,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":47},"100623627","preoperative-evaluation-of-ivc-collapsibility-index-and-caval-aorta-index-after-induction-of-general-anesthesia-100623627","NCT07399093","Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index After Induction of General Anesthesia","Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index for Prediction of Hypotension After Induction of General Anesthesia in Patients Undergoing Craniotomy Surgeries","Inclusion Criteria:\n\n* Age from 18 to 40 years.\n* Both sexes.\n* Body Mass Index\\\u003C 40 kg\u002Fm².\n* American Society of Anesthesiologists (ASA) physical status I, II.\n* Fasted according to the ASA guidelines: 2 hours for clear fluids, 6 hours after light meal, 8 hours after a full meal with high calorie or fat content.\n* Scheduled for elective craniotomy surgeries before induction of general anesthesia.\n\nExclusion Criteria:\n\n* Current or recent pregnancy (within 3 months).\n* Pre-existing cardiac disease or hypertension.\n* On medications affecting blood pressure \\[Beta-blockers (BBs) and calcium channel blockers (CCBs)\\] .\n* Refusing to undergo the study.",true,"40 Years",{"count":116,"type":21},36,"This study aims to assess the accuracy, repeatability, and reproducibility of preoperative evaluation of Inferior Vena Cava (IVC) collapsibility index and caval aorta index for prediction of hypotension after induction of general anesthesia.",[119,120,121,122,123,27],"Inferior Vena Cava","Collapsibility Index","Caval Aorta Index","Induction","General Anesthesia","2026-02-05",{"date":126,"type":39},"2026-02-10",{"date":128,"type":39},"2024-01-14",{"date":130,"type":21},"2026-03-01",{"name":132,"class":46},"Ain Shams University",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":141,"enrollmentInfo":142,"targetDuration":144,"studyType":59,"phases":4,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":47},"100380159","prospective-observational-real-world-treatments-of-aedh-in-large-scale-surgical-cases-100380159","NCT04229966","Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases","A Real World, Multicenter, Prospective, Observational Study to Compare Effectiveness of Surgical Treatments in Patients With Acute Epidural Hematoma","PORTALS-AEDH","Inclusion Criteria:\n\n1. Clear medical history of traumatic brain injury;\n2. within 12 hours after injury;\n3. Supratentorial unilateral acute epidural hematoma on first head CT scan examination;\n4. The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with surgical treatment;\n5. With informed consent to surgery and trial participation.\n\nExclusion Criteria:\n\n1. Previous intracranial surgery prior to trauma;\n2. Patients with a score of 3 on the GCS, with bilateral fixed and dilated pupils, bleeding diathesis or defective coagulation, or an injury that was deemed to be unsurvivable;\n3. CT demonstrates associated other intracranial hematomas e.g. subdural, intracerebral hemorrhage, or large size infarction, which are the main causes of operation;\n4. Patients who had injury of the oculomotor nerve;\n5. Severe pre-existing disability or severe co-morbidity which would lead to a poor outcome even if the patient is supposed to a good recovery from the TBI;\n6. Pregnant female.","65 Years",{"count":143,"type":21},2000,"6 Months","This is a multicenter, prospective, and observational real-world study aimed at investigating the current situation of surgical treatments and prognosis for acute epidural hematoma in China, and analyzing the optimization of therapy.",[147,148,27],"Epidural Hematoma","Decompressive Craniectomy","2026-01-12",{"date":151,"type":39},"2026-01-14",{"date":153,"type":39},"2020-11-02",{"date":155,"type":21},"2027-12-31",{"name":157,"class":46},"RenJi Hospital",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":141,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":178,"leadSponsor":180,"locationsCount":47},"100592476","dexmedetomidine-as-an-adjuvant-to-bupivacaine-in-scalp-block-versus-bupivacaine-alone-for-postoperative-pain-management-in-patients-undergoing-craniotomy-100592476","NCT06993922","Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management in Patients Undergoing Craniotomy","Inclusion Criteria:\n\n* Age from 18 to 65 years.\n* Both sexes.\n* American Society of Anesthesiologists (ASA) physical status I or II.\n* Undergoing supratentorial elective planned craniotomies.\n\nExclusion Criteria:\n\n* Patients refusal.\n* History of known allergy to the used local anesthetic or dexmedetomidine.\n* Bleeding disorders.\n* Evidence of local infection at the site of injection.\n* Emergency craniotomy.\n* Psychotic disorder.\n* Patients who will not be extubated in the operating room after surgery.",{"count":165,"type":21},50,[24],"This study aims to compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy.",[169,170,171,172,173,27],"Dexmedetomidine","Adjuvant","Bupivacaine","Scalp Block","Postoperative Pain","2025-05-29",{"date":176,"type":39},"2025-05-30",{"date":174,"type":39},{"date":179,"type":21},"2025-11-01",{"name":132,"class":46},{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":190,"conditions":191,"keywords":196,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":213},"100504719","study-on-prognosis-of-acutely-ruptured-intracranial-aneurysms-100504719","NCT05851989","Study on Prognosis of Acutely Ruptured Intracranial Aneurysms","SPARTA","Inclusion Criteria:\n\n* Confirmed diagnosis of subarachnoid haemorrhage on CT-scan or lumbar puncture (in the presence of a negative CT-scan)\n* Intracranial aneurysm proven within 6 months to be the cause of subarachnoid haemorrhage\n* Age 18 years or over at presentation.\n* Written informed consent\n\nExclusion Criteria:\n\n* Subarachnoid haemorrhage deemed most likely of 'perimesencephalic' origin after consideration of history, clinical examination and radiological findings (including angiographic imaging)\n* Subarachnoid haemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging)\n* Diagnosis of intracerebral arteriovenous malformations or dural arteriovenous fistula.\n* No diagnosis of intracranial aneurysm at 6 months after onset of symptoms.\n* Not mastering the Dutch language",{"count":189,"type":21},880,"The SPARTA study is a prospective multicenter observational trial in the Netherlands with the aim of identifying the best clinical care in patients with aneurysmal subarachnoidal haemorrhage. Differences in outcome between surgical treatment and endovascular treatment will be explored.\n\nFurthermore, cost effectiveness and radiological prognostic factors will be examined.",[192,193,27,194,195],"Aneurysmal Subarachnoid Hemorrhage","Endovascular Procedures","Patient Outcome Assessment","Treatment Outcome",[197,198,199,200,201,202,203],"Aneurysmal subarachnoid hemorrhage","Clipping","Neurosurgery","Coiling","Endovascular treatment","Outcome","Modified Rankin Scale","2025-03-22",{"date":206,"type":39},"2025-03-25",{"date":208,"type":39},"2021-07-14",{"date":210,"type":21},"2034-07-14",{"name":212,"class":46},"Haaglanden Medical Centre",6,{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":47},"100576097","a-pilot-clinical-study-to-evidence-improved-cranial-flap-fixation-with-a-bioresorbable-bone-adhesive-100576097","NCT06780852","A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive","A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive Based on Imaging and Patient Reported Outcomes","Inclusion Criteria:\n\nSubjects or representatives must have voluntarily signed the informed consent form before any study related procedures;\n\n* Subjects can be any gender, but be between (and including) 18 and 75 years of age\n* Subject is scheduled for a cranial procedure in the supratentorial location.\n* Subject requires a procedure involving a Class I\u002Fclean wound (uninfected surgical wound in which no inflammation was encountered).\n* Subject, and\u002For subject's family are able and willing to provide informed consent and HIPAA authorization.\n* Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.\n\nIntra-Operative Inclusion Criteria:\n\n* Width of craniotomy kerf line \\\u003C 3mm for more than 75% of the bone flap border\n\nExclusion Criteria:\n\n* Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells were appropriately sealed (e.g., bone wax).\n* Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.\n* Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy was not exclusionary).\n* Subject requires a craniectomy (the bone flap is not replaced during the current surgery).\n* Subject had radiation treatment to the surgical site, or standard fractionated radiation therapy was planned post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure was not an exclusion criterion.)\n* Subject requires a craniotomy across the sinus for which Tetranite is applied adjacent to or within the sinus to fixate the cranial flap.\n* Subject has a condition with anticipated survival shorter than six months.\n* Subject has undergone chemotherapy treatment, excluding hormonal therapy, within three weeks prior to the planned index procedure, or use of intracavitary chemotherapy wafer (BCNU) was planned, or chemotherapy treatment was planned within two weeks after the index procedure was performed.\n* Standard use of peri-operative steroids (i.e., corticosteroids) is permitted. Chronic steroid use (defined as daily use of corticosteroids for ≥ 8 weeks) for the purposes of reducing the side effects of chemotherapy and\u002For radiation therapy for cancer is not exclusionary unless the patient is deemed by the investigator to be suffering from steroid toxicity (i.e., Cushing's syndrome) manifested by symptoms and signs such as thin skin, striae, easy bruising, muscle atrophy, upper body obesity, severe fatigue, etc. Use of corticosteroids on a chronic basis (as defined previously) for purposes other than decreasing the symptoms of systemic chemotherapy is exclusionary unless those steroids were discontinued 4 weeks prior to the planned index procedure.\n* Subject receives warfarin, heparin, other anticoagulant agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.\n* Subject is pregnant, breast-feeding, or intended to become pregnant during the course of the study.","75 Years",{"count":223,"type":21},15,[24],"This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months). The aim of this Pilot Study is to demonstrate the safety and efficacy of the use of Tetranite for Cranial Flap Fixation (TN-CFF) to allow clinical study of the TN-CFF device in a greater number of patients.",[27],[228,229,230],"cranial flap fixation","bone adhesive","bioresorbable","2025-03-06",{"date":233,"type":39},"2025-03-11",{"date":235,"type":39},"2025-01-15",{"date":237,"type":21},"2027-01-15",{"name":104,"class":105}]