[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"csf-leakage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:csf-leakage":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100634446","phase-2-efficacy-and-safety-evaluation-of-absorbable-and-moldable-skull-base-support-plates-in-extended-endoscopic-endonasal-transsphenoidal-surgery-a-prospective-randomized-controlled-study-100634446",false,"NCT07539792","Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study","EEEA-AMSBP","Inclusion Criteria:\n\n1. Aged 1-80 years, regardless of gender;\n2. Diagnosed with sellar region tumors confirmed by clinical symptoms, endocrine examinations, and imaging data;\n3. Planned to undergo extended endoscopic endonasal transsphenoidal approach surgery as determined by departmental discussion;\n4. Karnofsky Performance Status score ≥ 70, with an expected survival period ≥ 24 months;\n5. Laboratory indicators (such as liver and kidney function, blood routine, etc.) within the normal range or controllable range;\n6. Sign the informed consent form and are willing to participate in the study.\n\nExclusion Criteria:\n\n1. Patients with other concurrent intracranial tumors or severe brain lesions;\n2. Patients scheduled to undergo craniotomy or non-extended endoscopic endonasal transsphenoidal surgery;\n3. Patients with uncontrolled severe heart, lung, kidney, or liver diseases;\n4. Pregnant or lactating women;\n5. Patients who have previously received radiotherapy or chemotherapy;\n6. Patients with active nasal infections, inflammation, or severe nasal diseases;\n7. Patients with a history of severe allergies to drugs or synthetic materials;\n8. Patients with extensive skull base bone destruction evaluated by preoperative imaging, for whom it is estimated that support materials cannot be used during surgery;\n9. Patients with mental illness or cognitive impairment who are unable to complete follow-up or understand the purpose of the study.","ALL","1 Year","80 Years",{"count":20,"type":21},126,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Primary objective: To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month after surgery.\n\nSecondary objectives:\n\n1. To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of intracranial infection within 1 months after surgery;\n2. To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the duration of the surgery and length of postoperative hospital stay;\n3. To monitor and evaluate the safety of absorbable and moldable skull base support plates, especially the occurrence of nasal complications.",[27,28,29],"Sellar Tumor","Endonasal Surgery","Csf Leakage",[27,31,32,33],"Extended Endoscopic Endonasal Transsphenoidal Surgery","Cerebrospinal Fluid Rhinorrhea","Skull Base Reconstruction","RECRUITING","2026-04-13",{"date":37,"type":38},"2026-04-20","ACTUAL",{"date":40,"type":38},"2026-04-01",{"date":42,"type":21},"2030-02-28",{"name":44,"class":45},"Nanfang Hospital, Southern Medical University","OTHER",8]