[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Airiver Medical, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100607692","paclitaxel-coated-pulmonary-balloon-for-the-treatment-of-benign-central-airway-stenosis-100607692","NCT07191860","Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Central Airway Stenosis","A Randomized, Controlled, Multi-Center, Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis (OXYGEN-RCT Trial)","OXYGEN-RCT","Inclusion Criteria:\n\n1. Age ≥ 22 years.\n2. Symptomatic de-novo or restenotic benign central airway stenosis in the subglottis, trachea, or mainstem bronchi with at least 50% narrowing, as determined by CT or bronchoscopy.\n3. In the opinion of the investigator, subject can undergo laryngoscopy\u002Fbronchoscopy under general anesthesia and has a central airway stenosis amenable to balloon dilation.\n4. For idiopathic subglottic stenoses, either de-novo or a dilation interval equal to or less than 18 months.\n5. Target benign stenosis etiologies including:\n\n   1. Post-intubation stenosis,\n   2. Idiopathic subglottic stenosis,\n   3. Post-transplantation stenosis,\n   4. Non-malignant trachea-bronchial stenosis\n6. Willing and able to complete protocol required follow-up visits.\n7. Willing and able to provide written informed consent.\n\nExclusion Criteria:1. Two or more clinically significant (e.g. non-traversable) stenoses with total length \\>5cm or unable to be treated with a single balloon 2. Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months 3. Subject currently has a stent at target stenosis location or has had a stent at the target location within the past 90 days.\n\n4\\. Subject has existing tracheostomy or had a tracheostomy within past 90 days 5. Contraindication to laryngoscopy\u002Fbronchoscopy, anesthesia, or deep sedation 6. Planned tracheal resection in the next 90 days. 7. Dynamic etiology of benign stenosis such as excessive dynamic airway collapse, tracheobronchomalacia, or stenosis due to external compression, or past tracheostomy which requires stent placement or surgical referral 8. Inclusion of vocal cord in target stenosis 9. Known medically significant unresolved lower respiratory tract infection, such as pneumonia, fungus, tuberculosis, etc.unrelated to stenosis 10. Target stenosis is beyond the mainstem bronchi 11. Signs or suspicion of a malignant airway obstruction NOTE: If obstruction is suspicious for malignancy based on clinical or laryngoscopic\u002Fbronchoscopic presentation, malignancy must be excluded by biopsy prior to randomization 12. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure 13. Chronic steroid use exceeding more than 10 mg per day for any medical condition including immunosuppression post-lung transplant or autoimmune associated airway suppression.\n\n14\\. Received local steroid or chemotherapeutic treatments into target stenosis in the last 12 weeks or planned treatment during index or staged study procedure.\n\n15\\. Planned serial intralesional steroid injections (SILSIs) post index procedure.\n\n16\\. Stenosis not amenable to laryngoscopic\u002Fbronchoscopic dilation in the opinion of the investigator 17. Acute condition that requires emergent procedure prior to screening assessment 18. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, ongoing infection, etc 19. Subject has known fistula between tracheobronchial tree and esophagus, mediastinum to pleural space.\n\n20\\. Subject has vasculitis that is not well controlled in the opinion of the investigator.\n\n21\\. Diagnosed with a disease requiring chemotherapy (e.g. cancer). 22. Allergy to paclitaxel or structurally related compounds 23. Target stenosis is within a transplanted lung or transplant anastomosis, or a tracheal resection anastomosis, which has been transplanted or resected within the last 60 days.\n\n24\\. Target stenosis is related to radiation therapy 25. Subject has a life expectancy of less than 2 years. 26. Current participation in another pre-market drug or medical device clinical study that has not reached its primary endpoint.\n\n\\-","22 Years",{"count":51,"type":21},200,[24],"The OXYGEN-RCT trial is a randomized, controlled, double blinded, prospective, multi-center trial to demonstrate the safety and efficacy in adult benign central airway stenosis. Participates will be in a 1:1 allocation to treatment with the Airiver Pulmonary DCB or standard of care laryngoscopic\u002Fbronchoscopic balloon dilation, respectively.",[55,56,57,58,59,60],"Adult Subjects With Symptomatic Benign Airway Obstruction","Adult Benign Central Airway Stenosis","Adult Tracheobronchial Stenosis","Tracheal Stenosis","Central Airway Stenosis","Central Airway Obstruction","2026-06-16",{"date":29,"type":32},{"date":64,"type":32},"2026-02-24",{"date":66,"type":21},"2030-11-01",{"name":38,"class":39},1,""]