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New treatment option for Adult Subjects With Symptomatic Benign Airway Obstruction
Official title Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Central Airway Stenosis
ClinicalTrials.gov ID: NCT07191860
What this study is testing
What is The Airiver Pulmonary drug-coated balloon (DCB) dilation?
The Airiver Pulmonary drug-coated balloon (DCB) dilation is an investigational medicine, being studied as a potential treatment for adult subjects with symptomatic benign airway obstruction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Age ≥ 22 years.
- Symptomatic de-novo or restenotic benign central airway stenosis in the subglottis, trachea, or mainstem bronchi with at least 50% narrowing, as...
- In the opinion of the investigator, subject can undergo laryngoscopy/bronchoscopy under general anesthesia and has a central airway stenosis amenable...
- For idiopathic subglottic stenoses, either de-novo or a dilation interval equal to or less than 18 months.
- Target benign stenosis etiologies including:
You likely can't join if
- 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...
- 4\. Subject has existing tracheostomy or had a tracheostomy within past 90 days 5. Contraindication to laryngoscopy/bronchoscopy, anesthesia, or deep...
- 14\. Received local steroid or chemotherapeutic treatments into target stenosis in the last 12 weeks or planned treatment during index or staged...
- 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...
- 20\. Subject has vasculitis that is not well controlled in the opinion of the investigator.
See the full eligibility criteria
- Age ≥ 22 years.
- 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.
- In the opinion of the investigator, subject can undergo laryngoscopy/bronchoscopy under general anesthesia and has a central airway stenosis amenable to balloon dilation.
- For idiopathic subglottic stenoses, either de-novo or a dilation interval equal to or less than 18 months.
- Target benign stenosis etiologies including:
- Post-intubation stenosis,
- Idiopathic subglottic stenosis,
- Post-transplantation stenosis,
- Non-malignant trachea-bronchial stenosis
- Willing and able to complete protocol required follow-up visits.
- Willing and able to provide written informed consent.
- 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 people who are pregnant or breastfeeding or plan to become pregnant...
- 4\. Subject has existing tracheostomy or had a tracheostomy within past 90 days 5. Contraindication to laryngoscopy/bronchoscopy, anesthesia, or deep sedation 6. Planned tracheal resection in the next 90 days. 7...
- 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...
- 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...
- 24\. 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...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.