Is NCT07191860 recruiting in Baltimore, MD?

Yes, NCT07191860 is currently recruiting participants at its Baltimore, MD location. This adult subjects with symptomatic benign airway obstruction clinical trial is actively enrolling qualified participants.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Adult Subjects With Symptomatic Benign Airway Obstruction Clinical Trial in Baltimore, MD

Q: How do I join the adult subjects with symptomatic benign airway obstruction clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Adult Subjects With Symptomatic Benign Airway Obstruction Study in Baltimore

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.

Sponsor: Airiver Medical, Inc.

Who Can Participate

Inclusion 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.

Exclusion Criteria

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. 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. 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/bronchoscopic 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. 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 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. \-

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT07191860) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Adult Subjects With Symptomatic Benign Airway Obstruction Treatment Options in Baltimore, MD

If you're searching for adult subjects with symptomatic benign airway obstruction treatment options in Baltimore, MD, this clinical trial (NCT07191860) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced adult subjects with symptomatic benign airway obstruction specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all adult subjects with symptomatic benign airway obstruction clinical trials near you to find additional studies recruiting in your area.

Adult Subjects With Symptomatic Benign Airway Obstruction Clinical Trial in Baltimore, MD

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