[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-rhinosinusitis-crs-with-and-without-nasal-polyps\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-rhinosinusitis-crs-with-and-without-nasal-polyps":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100615248","paclitaxel-coated-balloon-treatment-of-chronic-rhinosinusitis-100615248",false,"NCT07290140","Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis","A Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Safety and Efficacy of Paclitaxel-Coated Sinus Balloon as an Adjunct to Endoscopic Sinus Surgery in Adult Chronic Rhinosinusitis Subjects","RESTORE-2 RCT","Inclusion Criteria:\n\n1. Male or female, aged ≥18 years\n2. Confirmed diagnosis of CRS per the 2021 \"International Consensus Statement on Allergy and Rhinology: Rhinosinusitis\" definition.\n3. Radiographic evidence of bilateral ethmoid disease on CT taken 6 months or less prior to study index procedure and at least 6 months after any prior ESS or nasal surgery, polypectomy, balloon sinus dilation, etc. as applicable\n4. Radiographic evidence of bilateral frontal sinus and\u002For frontal sinus outflow tract disease\n5. Baseline SNOT-22 score ≥ 30\n6. Has failed previous medical treatment and is an appropriate candidate for primary or revision ESS of bilateral ethmoid sinuses and bilateral frontal\u002Ffrontal sinus outflow tract\n7. Willing and able to provide written informed consent\n8. Willing and able to comply with all protocol follow up visits and assessments\n\nExclusion Criteria:\n\n1. Nasal cavity tumor (malignant or benign)\n2. Antrochoanal polyps\n3. Previous complete middle turbinate resection\n4. Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)\n5. History of prior lamina dehiscence or cerebrospinal fluid (CSF) leak in skull-based dehiscence\n6. Concurrent condition requiring active chemotherapy and\u002For immunotherapy management\n7. Subjects whose symptoms are too severe to undergo ESS (e.g., temperature \\>102.5F or extra-sinus manifestations, such as orbital cellulitis; dental or facial or brain abscess; cavernous vein thrombosis; or altered mental status\n8. History of complications from prior ESS or balloon dilation procedure (e.g., CSF leak or injury to the skull base or orbital injury)\n9. History of primary ciliary dyskinesia\n10. Oral-steroid dependent conditions such as chronic obstructive pulmonary disease (COPD) or other conditions\n11. Have evidence of significant baseline mucosal injury, ulceration, or erosion (e.g., exposed cartilage, perforation) on nasal examination\n12. Acute purulent nasal infection or upper respiratory tract infection, including but not limited to acute bacterial rhinosinusitis (ABRS), acute rhinosinusitis (ARS), or COVID -19 within 2 weeks before the baseline visit.\n13. Allergy or hypersensitivity to paclitaxel or structurally related compounds.\n14. Subject has taken biologic drugs in the 6 months leading up to the screening visit or who expect to take biologics in the next 24 months.\n15. Subject has taken oral corticosteroids in the 30 days leading up to their baseline appointment.\n16. Subject who plans to undergo posterior nasal nerve ablation in the next 24 months.\n17. Subject has a history of inability to tolerate nasal endoscopy\n18. Concurrent medical condition that would affect the investigator's ability to evaluate the subject's condition or that could compromise subject safety, such as severe COPD, severe asthma\n19. Pregnant or planning to become pregnant during the first 12 months of enrollment in the study\n20. Subject who has undergone a nasal\u002Fsinus surgery including but not limited to ESS, polypectomy, septoplasty, turbinoplasty, balloon sinus dilation, placement of steroid releasing implants, posterior nasal nerve ablation in the 6 months prior to the baseline appointment.\n21. Previous Draf III frontal sinus surgery or a study index procedure ESS is expected to be or is a Draf III sinus surgery.\n22. Subject whose index procedure did not include bilateral ethmoid ESS and bilateral frontal ESS\n23. Subject whose expected study index procedure includes steroid releasing implants or non-resorbable nasal packing\u002Fstents.\n24. Subject whose study index procedure is aborted for any reason\n25. Life expectancy \\\u003C2 years","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, multicenter, randomized, controlled, double-blind clinical trial enrolling 300 adult subjects with chronic rhinosinusitis (CRS) with and without nasal polyps (CRSwNP and CRSsNP) indicated for endoscopic sinus surgery (ESS).",[27],"Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps","RECRUITING","2026-06-18",{"date":31,"type":32},"2026-06-22","ACTUAL",{"date":34,"type":32},"2026-06-01",{"date":36,"type":21},"2031-03-01",{"name":38,"class":39},"Airiver Medical, Inc.","INDUSTRY",8,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100590711","crs-questionnaire-validation-project-100590711","NCT06970977","CRS Questionnaire Validation Project","Inclusion Criteria:\n\n* Patient capable of giving informed consent\n* Diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines\n* No recent sinus surgery (within the last three months)\n\nExclusion Criteria:\n\n* Not capable of giving informed consent\n* No CRS\n* Recent sinus surgery (within the last three months)",{"count":48,"type":21},1000,"OBSERVATIONAL","The 'CRS validation project' consists of a joint effort of 32 medical centers in Europe, the USA, and South Africa to carry out the validation of 2 novel questionnaires designated to measure self-perceived severity and control of Chronic Rhinosinusitis (with or without nasal polyps).\n\nThis study will validate translated versions of the same set of questionnaires simultaneously in the centers involved after recruiting a total of 1000 patients, while data collection, statistical analysis, and creation of the study report will be carried out by the statistical department of the University of Leuven.\n\nPatients will be recruited from the regular ENT practice of their hospital to minimize the complexity of the study.",[27],"2025-08-06",{"date":54,"type":32},"2025-08-07",{"date":56,"type":32},"2024-09-01",{"date":58,"type":21},"2026-09-30",{"name":60,"class":61},"The European Forum for Research and Education in Allergy and Airway Diseases","OTHER",32,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":72,"targetDuration":74,"studyType":49,"phases":4,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100578739","the-german-national-crs-registry-genrecrs-clinical-evaluation-of-the-new-european-academy-for-allergy-and-clinical-immunology-eaaci-criteria-for-crswnp-disease-control-remission-and-cure-in-a-real-world-evidence-study-approach-100578739","NCT06815211","The German National CRS Registry (GenreCRS): Clinical Evaluation of the New European Academy for Allergy and Clinical Immunology (EAACI) Criteria for CRSwNP Disease Control, Remission and Cure in a Real-World Evidence Study Approach","A Prospective Study for Real-world Evaluation of the Novel European Academy for Allergy and Clinical Immunology (EAACI) Criteria for Disease Control, Remission and Cure in CRSwNP Utilizing the German National CRS Registry (GENRE CRS)","GenreCRS","Inclusion Criteria:\n\n* Patients above the age of 12 years\n* Patients who are diagnosed with CRS according to internationally valid guidelines (EPOS 2020)\n* Patients who provide written informed consent or by a legal representative\n\nExclusion Criteria:\n\n* Patients below the age of 12 years at initiation\n* Patients who do not provide written consent or withdraw their consent","12 Years",{"count":73,"type":21},500,"1 Year","The objective of the study is to establish a registry of patients diagnosed with Chronic Rhinosinusitis with and without Nasal Polyps (CRSwNP\u002FCRSsNP) to collect comprehensive longitudinal real-world evidence from specialised treatment centres in Germany. The primary analysis will concentrate on the treatment efficacy and safety of biologic drugs with a focus on defining disease Control, Remission, and Cure as well as to validate the corresponding clinical evaluation criteria.",[77,27],"Chronic Rhinosinusitis (CRS)",[79,80,81,82,83],"CRSwNP","CRSsNP","Nasal Polyps","Registry","Patient Reported Outcome Measures (PROM)","NOT_YET_RECRUITING","2025-06-03",{"date":87,"type":32},"2025-06-04",{"date":89,"type":21},"2025-10",{"date":91,"type":21},"2028-10",{"name":93,"class":61},"Ärzteverband Deutscher Allergologen e.V."]