Who is eligible for clinical trial NCT05050591?

Participants must meet protocol criteria for Pulmonary Disease, Chronic Obstructive. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05050591 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-01-31

Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent (NCT05050591)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: VisionAir Solutions

🩺 Plain-English Summary (8th-Grade Level)

The goal of the trial is to establish a method, material, and patient-specific stent design that will last longer, fit better, and cause less trauma to the airway and the patient.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (11 items).

Location: Mayo Clinic — Rochester, Minnesota

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Patients will be considered for study inclusion if they have a clinical need for airway stenting defined by prior evidence of existing stents that have at least temporarily improved symptoms, but now suffer from stent complications; or those for whom a stent would be offered if an appropriate size and shape was available. Subjects must meet the following inclusion/exclusion criteria to be eligible for the study.
Understand and voluntarily sign an informed consent form.
Patients must be at least 22 years of age
Patients must be able to undergo routine non-contrast CT scans of the chest
Patient must be stable for general anesthesia and have an airway amenable to rigid bronchoscopy and stent implantation.
The patients must have at least an expected 6 month survival.
Patient must be able to maintain standard of care follow-up schedule and have access to standard of care medications and nebulizer machines and/or suction and oxygen as required for primary disease management.
Patient must be able to personally provide consent and be able to describe Dyspnea and QOL and other patient-reported outcomes (PROs) required by study design
Patient must require a stent that is within the design envelope of the patient-specific stents, as defined by COS (See Section 5.4 of this protocol for envelope)

Usually NOT eligible if any of the following apply:

Exclusion Criteria: Patients may be excluded if management of the airway problem can be safely and effectively treated with commercially available stents (SOC), non-stenting techniques, or surgical options.
Patients may be excluded if the disease can be managed by simply removing prior stents or performing more conservative therapies.
Chronic anticoagulant therapy that could limit the safety of performing rigid therapeutic bronchoscopy in a timely manner. (I.e. Plavix within one year of drug eluding cardiac stent (DES) or 6 weeks following bare metal coronary stent)
Unstable cardiac disease
Allergy to silicone
Stenting to manage vascular compression syndromes.
Multi-drug resistant bacterial or fungal chronic infections
Emergent/urgent clinically indicated stent.
Chronic/permanent mechanical ventilation.
Pure Excessive Dynamic Airway Collapse (EDAC) patients.
Pure Pulmonary Resistance (Rp) patients.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Mayo Clinic — Rochester, Minnesota
Pulmonary Medicine — Cleveland, Ohio

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗