An interventional study of The Airiver Pulmonary drug-coated balloon (DCB) dilation and Commercial airway balloon dilation in Adult Subjects With Symptomatic Benign Airway Obstruction, Adult Benign Central Airway Stenosis and Adult Tracheobronchial Stenosis, sponsored by Airiver Medical, Inc.. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Airiver Medical, Inc. · Not applicable, Interventional, and Treatment
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/bronchoscopic balloon dilation, respectively.
Subjects will complete follow-up post-treatment at 30 days, 3 months, 6 months, 12 months, and every 6 months after through the primary endpoint, with a minimum of 2 years at study end.
42 studies on the registry are indexed under Tracheal Stenosis; 11 are open to participants now.
This study's planned enrollment of 200 is above the median of 22 across 24 interventional studies indexed under Tracheal Stenosis.
Browse Tracheal Stenosis studies →Airiver Medical, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Target benign stenosis etiologies including:
Exclusion Criteria:1. Two or more (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.
4. Subject has existing tracheostomy or had a tracheostomy within past 90 days 5. to laryngoscopy/bronchoscopy, 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 based on clinical or laryngoscopic/bronchoscopic presentation, malignancy must be excluded by 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 use exceeding more than 10 mg per day for any medical condition including post-lung transplant or associated airway suppression.
14. Received local steroid or chemotherapeutic treatments into target stenosis in the last 12 weeks or planned treatment during index or staged study procedure.
15. Planned serial intralesional steroid injections (SILSIs) post index procedure.
16. Stenosis not amenable to laryngoscopic/bronchoscopic 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.
20. Subject has vasculitis that is not well controlled in the opinion of the investigator.
21. 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.
24. Target stenosis is related to radiation therapy 25. Subject has a 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.
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
dilate benign stenoses of the airway tree.
Combination Product: The Airiver Pulmonary drug-coated balloon (DCB) dilation
dilate benign stenoses of the airway tree.
Device: Commercial airway balloon dilation
drug coated balloon dilation
uncoated airway balloon dilation
Primary Safety: defined as Incidence of device- and/or procedure-related Major Adverse Events(MAEs)
including: * Pneumothorax * Pneumomediastinum * Tracheal or bronchial laceration requiring intervention * Airway perforation or rupture * Required tracheostomy * Bleeding from treatment site consistent with massive hemoptysis defined as \> 100mL of blood expectorated in 24 hours or requiring transfusion * Mediastinitis requiring the need for IV antibiotics and / or hospitalization * Respiratory distress or asphyxia requiring intubation or reintervention * Death
Time frame: 30 days post index procedure
Primary Efficacy: freedom from clinically indicated target lesion re-intervention over time
defined as a therapeutic reintervention/dilation that occurs due to either a recurrence of patient symptoms due to the stenosis and/or a recurrence seen through imaging of the stenosis (≥ 50%) or is an emergent condition related to the stenosis and treatment is required.
Time frame: Through the study completion, an average of 1 year
Time to first reintervention, defined as duration in days between the index/staged procedure and the first, subsequent procedure for treatment of the target stenosis.
Hypothesis-test
Time frame: From Day 1 until the date of first documented reintervention, assessed through the study completion, an average of 1 year.
Percent change in airway lumen area at 6 months by CT
Hypothesis-test. The percent change expressed as the airway lumen volume within the treated segment at 6 months (Area 6mo), compared to the personal baseline airway lumen volume (AreaBL) on CT scan. Percent change in airway luminal area = (Area6mo - AreaBL) / AreaBL ×100%
Time frame: Baseline, 6 months
Change in Peak Expiratory Flow (PEF) from 30 days to 6 months
Hypothesis-test. PEF in L/min
Time frame: 1 month, 6 months
Index procedure success, defined as the ability to deliver study device to the targeted stenosis, inflate, deflate, and remove and with a < 25% residual stenosis.
Non-hypothesis test. NO device malfunction issues. Use visual estimation under bronchoscopy at the end of index procedure, compare post-treated airway diameter (TD, mm) versus airway native diameter (ND, mm), residual stenosis = (ND- TD)/NDx100%
Time frame: On index procedure day 0
Change in airway lumen volume by CT at follow-up visit
Non-hypothesis test. Change in lumen volume in percentage (%). The percent change expressed as the airway lumen volume within the treated segment at follow-up (AreaFU) compared to the personal baseline airway lumen volume (AreaBL) on CT scan. Percent change in airway luminal area = (AreaFU - AreaBL) / AreaBL ×100%
Time frame: Baseline, 30 days, 6 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years)
Freedom from reintervention, defined as any reintervention on the target stenosis, whether clinically indicated or not
Non-hypothesis test
Time frame: 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study complete (assessed up to 2 years)
Annualized rate, of reinterventions
Non-hypothesis test
Time frame: Assessed annually through the date of the study complete, an average of 1 year.
Secondary patency, defined as freedom from reintervention after a first reintervention, at each follow-up
Non-hypothesis test
Time frame: From the date of the first reintervention to the next follow-up visit through the study completion, an average of 1 year.
Change in forced expiratory volume in 1 second (FEV1) at follow-up visit
Non-hypothesis test. FEV1 in liters
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date for the study complete (assessed up to 2 years)
Change in forced vital capacity (FVC) at follow-up visit
Non-hypnoses test. FVC in liters
Time frame: Baseline, 30 day, 3 months, 6 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years)
Changes in the ratio of FVE1 and FVC at follow-up visit
Non-hypnoses test. The Ratio =(FVE1/FVC) x100%
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years)
Change in peak expiratory flow (PEF)
Non-hypnoses test. PEF in liters per minute (L/min)
Time frame: Baseline, 3 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years).
Change in expiratory disproportion index (EDI)
Non-hypnoses test. EDI= (FEV1/PEF) x100%
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6month until the date of the study complete (assessed up to 2 years)
Rate of cannulation, stent, or open surgery due to target lesion stenosis
Non-hypothesis test
Time frame: 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study complete (assessed up to 2 years)
Change in modified Medical Research Council (mMRC) Dyspnea Scale
Non-hypothesis test. mMRC is a self-assessment tool and rated on a scale from 0 to 4, where a higher score means a worse outcome.
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study completion (assessed up to 2 years)
Change in Chronic Obstructive Pulmonary Disease (COPD) Questionnaire
Non-hypnoses test. The questionnaire is rated on 0-6 scale, a higher score indicating a worse health status.
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study completion (assessed up to 2 years)
Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score
Non-hypnosis test. SF-12 is a self-reported outcome and rated on a 0-5 scale, where a higher score indicates better health.
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of the study completion (assessed up to 2 years)
Change in Voice Handicap Index (VHI-10) questionnaire
Non-hypnosis test. VHI-10 is a self-administered questionnaire and scored from 0 to 4, where a higher score indicates a greater voice -related handicap.
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the study completion (assessed up to 2 years)
Started Feb 2026 (actual). Primary completion is estimated for Nov 2027, 20 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Airiver Medical, Inc.