[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659112":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":56,"studyPopulation":47,"armGroups":57,"interventions":68,"overallOfficials":47,"centralContacts":78,"locations":85,"responsibleParty":133,"collaborators":47,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":47,"eligibilityCriteria":141,"healthyVolunteers":137,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":47,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":47,"overallStatus":88,"whyStopped":47,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Maxigen Biotech Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Hemostasis Rate at 24 Hours After Nasal Packing","Hemostasis will be assessed using a four-grade bleeding scale: 0 = no bleeding; 1 = minimal bleeding confined to the nasal cavity; 2 = moderate bleeding extending outside the nasal cavity without requiring repacking; and 3 = severe bleeding requiring repacking. The hemostasis rate will be compared between the NasoAid and NasoPore groups.","24 hours after nasal packing",[14,18,22,26,30,33,37,40,43],{"measure":15,"description":16,"timeFrame":17},"Hemostasis Rate at 2, 12, and 48 Hours After Nasal Packing","Hemostasis will be assessed using the same four-grade bleeding scale as the primary outcome: 0 = no bleeding; 1 = minimal bleeding confined to the nasal cavity; 2 = moderate bleeding extending outside the nasal cavity without requiring repacking; and 3 = severe bleeding requiring repacking. The hemostasis rates will be compared between the NasoAid and NasoPore groups.","2 hours, 12 hours, and 48 hours after nasal packing",{"measure":19,"description":20,"timeFrame":21},"Endoscopic Nasal Assessment Score","Endoscopic nasal assessment will evaluate four parameters: edema, discharge, scarring, and crusting. Each parameter is scored from 0 to 2, with higher scores indicating greater severity. The score for each side of the nasal cavity ranges from 0 to 8, resulting in a total score ranging from 0 to 16. Scores will be compared between the NasoAid and NasoPore groups.","Pre-surgery and at Weeks 2, 4, 8, and 12 after surgery",{"measure":23,"description":24,"timeFrame":25},"Remnant Nasal Packing Material","The amount of remnant nasal packing material in the middle meatus of each side will be assessed by nasal endoscopy before suction or removal. The remaining amount is graded as 0 = none, 1 = 25%, 2 = 25-50%, 3 = 50-75%, and 4 = greater than 75%. The ease of removing the nasal packing by suction or forceps will also be evaluated using a 0-to-10 scale, with 0 indicating very easy and 10 indicating extremely difficult.","Week 1 after surgery",{"measure":27,"description":28,"timeFrame":29},"Patient-Reported Visual Analog Scale (VAS) of General Assessment","Subjects will rate four aspects of their postoperative condition using 0-to-10 visual analog scales: severity of nasal symptoms, discomfort caused by nasal symptoms, discomfort caused by olfactory abnormalities, and the impact of nasal symptoms on sleep. Higher scores indicate greater symptom severity, discomfort, or impact.","Preo-surgery and at Weeks 1, 2, 4, 8, and 12 after surgery",{"measure":31,"description":32,"timeFrame":25},"Patient-Reported Visual Analog Scale (VAS) of Product Satisfaction","Subjects will assess their experience with the nasal packing using three 0-to-10 visual analog scales: pain caused by the nasal packing during packing, nasal breathing obstruction caused by the packing, and pain during removal of the nasal packing. Higher scores indicate greater pain or obstruction.",{"measure":34,"description":35,"timeFrame":36},"Sino-Nasal Outcome Test-22 (SNOT-22) Score","The SNOT-22 consists of 22 patient-reported items assessing sinonasal symptoms and related social and emotional impacts. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be), resulting in a total score ranging from 0 to 110.","Pre-surgery and at Weeks 1, 2, 4, 8, and 12 after surgery",{"measure":38,"description":39,"timeFrame":36},"Nasal Obstruction Symptom Evaluation (NOSE) Score","The NOSE scale consists of five patient-reported items related to nasal obstruction. Each item is scored from 0 (not a problem) to 4 (severe problem). The sum of the five item scores is multiplied by 5 to obtain a total score ranging from 0 to 100. Higher scores indicate greater severity of nasal obstruction.",{"measure":41,"description":42,"timeFrame":36},"Total Nasal Symptom Score (TNSS)","The TNSS is a patient-reported assessment of four nasal symptoms: nasal congestion, nasal itching, sneezing, and runny nose. Each symptom is scored from 0 (no symptoms) to 3 (severe), resulting in a total score ranging from 0 to 12. Higher scores indicate greater nasal symptom severity.",{"measure":44,"description":45,"timeFrame":46},"Incidence of Medical Device-Related Adverse Events","The incidence will be calculated to represent the percentage of patients who experience medical device-related adverse and compared between the NasoAid and NasoPore groups.","Day 0 to Week 12",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":47,"primaryPurpose":51,"observationalModel":47,"timePerspective":47,"maskingInfo":52},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":53,"maskingDescription":47,"whoMasked":54},"SINGLE",[55],"PARTICIPANT","This study is conducted as a randomized, single-blind, multicenter, non-inferiority clinical trial to compare the use of two different nasal packing material, synthetic (NasoPore) versus collagen-based (NasoAid) in patients undergoing nasal surgery requiring nasal packing. Nasal packing material acts as an intranasal splint to minimize bleeding in nasal cavity or septum. Hemostasis will be assessed at 2, 12, 24 and 48 hours after surgery. Subjects will be followed for 12 weeks. Remnant percentage of nasal packing material will be evaluated at Weeks 1 after surgery. Endoscopic nasal assessments will be performed at Week 2, 4, 8, and 12 after surgery to evaluate nasal conditions. Patient-reported outcomes, including visual analog scales (VAS), Sino-Nasal Outcome Test-22 (SNOT-22), Nasal Obstruction Symptom Evaluation (NOSE score), and Total Nasal Symptom Score (TNSS), will be assessed before surgery and at Week 1, 2, 4, 8, and 12 after surgery. Safety data and adverse events would be recorded throughout the study.",[58,63],{"label":59,"type":60,"description":47,"interventionNames":61},"Treatment group (NasoAid)","EXPERIMENTAL",[62],"Device: NasoAid® Intranasal Splint",{"label":64,"type":65,"description":47,"interventionNames":66},"Control group (NasoPore)","ACTIVE_COMPARATOR",[67],"Device: \"Stryker\" NasoPore Nasal Dressing",[69,74],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":47},"DEVICE","NasoAid® Intranasal Splint","NasoAid® Intranasal Splint is an absorbable nasal packing device composed of collagen and carboxymethyl cellulose. Nasal packing will be applied at the end of surgery. The packing may be trimmed or reshaped intraoperatively by the surgeon to fit the cavity.",[59],{"type":70,"name":75,"description":76,"armGroupLabels":77,"otherNames":47},"\"Stryker\" NasoPore Nasal Dressing","\"Stryker\" NasoPore Nasal Dressing is a bioresorbable synthetic polyurethane foam nasal packing device. Nasal packing will be applied at the end of surgery. The packing may be trimmed or reshaped intraoperatively by the surgeon to fit the cavity.",[64],[79],{"name":80,"role":81,"phone":82,"phoneExt":83,"email":84},"LiRong Chen","CONTACT","+88633287222","1250","lirong.chen@mbi.com.tw",[86,105,118],{"facility":87,"status":88,"city":89,"state":47,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"National Taiwan University Hospital","RECRUITING","Taipei","100229","Taiwan","TW",{"type":94,"coordinates":95},"Point",[96,97],121.52639,25.05306,{"lat":97,"lon":96},[100],{"name":101,"role":81,"phone":102,"phoneExt":103,"email":104},"Chih-Feng Lin","+886223123456","65216","drlincf@gmail.com",{"facility":106,"status":107,"city":89,"state":47,"zip":108,"country":91,"countryCode":92,"cosmosGeoPoint":109,"geoPoint":111,"contacts":112},"Taipei Veterans General Hospital","NOT_YET_RECRUITING","11217",{"type":94,"coordinates":110},[96,97],{"lat":97,"lon":96},[113],{"name":114,"role":81,"phone":115,"phoneExt":116,"email":117},"Yun-Ting Chao","+886228757337","112","yunting001@gmail.com",{"facility":119,"status":88,"city":120,"state":47,"zip":121,"country":91,"countryCode":92,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Chang Gung Memorial Hospital, Linkou","Taoyuan","333",{"type":94,"coordinates":123},[124,125],121.29696,24.99368,{"lat":125,"lon":124},[128],{"name":129,"role":81,"phone":130,"phoneExt":131,"email":132},"Chia-Hsiang Fu","+88633281200","8465","fufamily@cgmh.org.tw",{"type":134,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100659112","efficacy-and-safety-of-nasoaid-after-nasal-surgery-100659112",false,"NCT07861061","Efficacy and Safety of NasoAid® After Nasal Surgery","Efficacy and Safety of Collagen-Based Absorbable Nasal Packing (NasoAid®) After Nasal Surgery: A Prospective, Single-Blind, Randomized Controlled Multi-Center Trial","Inclusion Criteria:\n\n* Adults aged 18-75 years\n* Patients needing nasal surgery that requires bilateral nasal packing: types of operations include septomeatal plasty. The bilateral packing material will be trimmed to fit the size of the patient's wound or nasal cavity, at the physician's discretion.\n\nExclusion Criteria:\n\n* Severe anatomical abnormalities of the nasal cavity or sinuses, including trauma related structural changes, congenital craniofacial malformations, skull base defects or cerebrospinal fluid (CSF) leak, septal perforation, or other abnormalities that could interfere with the evaluation of study outcomes or pose a safety risk to the subject, as evaluated by the investigator.\n* Acute sinusitis with abscess formation or severe mucosal swelling.\n* Diagnosed with secondary chronic rhinosinusitis; however, patients with recurrence of the condition requiring additional surgery can be included in the study.\n* Benign or malignant tumors in the nasal cavity or sinuses.\n* Diagnosis of cystic fibrosis, primary ciliary dyskinesia (including Kartagener syndrome), or other conditions associated with impaired mucociliary clearance.\n* Patients with known allergies to collagen.\n* Patients receiving systemic corticosteroid therapy within the past 4 weeks, or ongoing corticosteroid treatment for any condition; however, patients using nasal spray therapy are allowed to participate.\n* Coagulation disorders and\u002For receiving anticoagulant therapy which impact the nasal surgery (e.g., International Normalize Ratio \\[INR\\] \\> 1.5). Patients with coagulation function suitable for surgery (INR ≤ 1.5) are eligible.\n* Uncontrolled chronic disease with risk factor for postoperative hemorrhage such as cardiovascular disease, diabetes mellitus and hypertension, as evaluated by the investigator.\n* Pregnancy or breastfeeding women.\n* Presence of any contraindication to surgical intervention, as evaluated by the investigator.\n* Unable to comply with the follow-up and postoperative care requirements.\n* Any clinically relevant condition, in the investigator's judgment, would interfere with the evaluation of study outcomes or pose a safety risk to the subject.\n* Participation in other interventional trials or studies.","ALL","18 Years","75 Years",{"count":146,"type":147},154,"ESTIMATED","INTERVENTIONAL",[150],"NA","The goal of this clinical trial is to evaluate the effectiveness and safety of collagen-based absorbable nasal packing (NasoAid®) after nasal surgery. The main question it aims to answer are:\n\n* The hemostasis 2, 12, 24, 48 hours after nasal packing.\n* The endoscopic nasal assessments scores.\n* The remnant percentage of nasal packing material.\n* Patient-reported Visual Analog Scale (VAS) scores for general assessment.\n* Patient-reported outcomes, including the Sino-Nasal Outcome Test-22 (SNOT-22), Nasal Obstruction Symptom Evaluation (NOSE), and Total Nasal Symptom Score (TNSS).\n* The incidences of safety indicators.\n\nParticipants will be randomized into either experiment group or control group, receive nasal packing at Day0, and re-visited on week 1, 2, 4, 8 and 12 after nasal surgery.\n\nResearchers will compare if NasoAid® is non-inferiority to NasoPore.",[153,154,155],"Nasal Surgery","Hemostasis","Nasal Packing","2026-09-30",{"date":158,"type":159},"2026-10-06","ACTUAL",{"date":161,"type":159},"2026-08-24",{"date":163,"type":147},"2027-07-31",{"name":5,"class":6},3]