[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"central-airway-obstruction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:central-airway-obstruction":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100607692","paclitaxel-coated-pulmonary-balloon-for-the-treatment-of-benign-central-airway-stenosis-100607692",false,"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\\-","ALL","22 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31,32],"Adult Subjects With Symptomatic Benign Airway Obstruction","Adult Benign Central Airway Stenosis","Adult Tracheobronchial Stenosis","Tracheal Stenosis","Central Airway Stenosis","Central Airway Obstruction","RECRUITING","2026-06-16",{"date":36,"type":37},"2026-06-18","ACTUAL",{"date":39,"type":37},"2026-02-24",{"date":41,"type":21},"2030-11-01",{"name":43,"class":44},"Airiver Medical, Inc.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":45},"100507013","to-investigate-airway-oxygen-concentrations-during-rigid-bronchoscopy-procedures-performed-with-high-frequency-jet-ventilation-100507013","NCT05881863","To Investigate Airway Oxygen Concentrations During Rigid Bronchoscopy Procedures Performed With High Frequency Jet Ventilation","Inclusion Criteria:\n\n* Patients undergoing rigid bronchoscopy for treatment of central airway obstruction at FV UMMC will be identified.\n* 18 years or older\n* Need rigid bronchoscopy as pre-determined by the interventional pulmonologist\n\nExclusion Criteria:\n\n* Refusal to sign consent\n* Pregnant patients\n* Hemodynamic instability defined as continuous infusion of medication in order to support blood pressure and\u002For heart rate\u002Frhythm\n* Respiratory instability defined as SpO2\\<90% with \\>90% supplemental oxygen.\n* Ineligible for rigid bronchoscopic intubation\n* Latex allergy\n* Evidence of fistulous airway\n* Active Bronchopleural fistula","18 Years",{"count":54,"type":21},50,"OBSERVATIONAL","Thermal ablation (use of treatment modalities that generate heat) has become a widely used tool for treatment of central airway obstruction (e.g. laser, electrocautery, radiofrequency, and argon plasma coagulation). However, this method carries with it an increased risk for airway fire - a surgical fire that occurs in a patient's airway and could also include a fire in the attached breathing circuit. To decrease the risk of airway fire during mechanical ventilation with an endotracheal tube, the concentration of inspired oxygen (FiO2) is set below 40% while waiting for end tidal oxygen concentration (EtO2) to fall below 40% prior to starting thermal ablation. There is no published literature describing O2 concentration within the airways (AiO2) during jet ventilation with rigid bronchoscopy. The co-investigators of this study have recently collected data on AiO2 during rigid bronchoscopy using manual low frequency jet ventilation\u002Fhigh frequency jet ventilation with a period of apnea. The intent of this study is to measure the time taken for the central airway oxygen concentration to drop from 90 to 40% when the \"laser mode\" is activated on the Monsoon jet ventilator. Ventilation is continued during \"laser mode.\"",[32],"2026-01-05",{"date":60,"type":37},"2026-01-07",{"date":62,"type":37},"2024-01-12",{"date":64,"type":21},"2026-12-31",{"name":66,"class":67},"University of Minnesota","OTHER"]