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Clinical Trials in the USA / NCT05050591
Active, not recruiting Not applicable

Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

NCT05050591 · tracked via the Priya Life Science USA tracker
Sponsor
VisionAir Solutions
Phase
Not applicable
Started
2021-08-05
Last updated
2025-02-05

Condition(s) studied

Pulmonary Disease, Chronic Obstructive

Investigational drug(s) / intervention(s)

Patient-Specific Silicone Airway Stent

Patient-Specific Silicone Airway Stent: The Patient-Specific Airway Stent is a silicone stent indicated for use in adults that have stenosis of the airway. Current silicone stents have stock dimensions that do not conform to the patient's airway anatomy. The subject device takes a CT scan, thresholds out the airway from the other anatomy, and allows the physician to digitally design the stent to his/her desired dimensions. Finally, according to the physician's design, a patient-specific stent can be manufactured using additive manufacturing technology. The patient-specific stent is indicated for use with any rigid bronchoscopy/stent application system that fits the design envelope.

Study summary

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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 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) 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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Mayo Clinic Rochester Minnesota
Pulmonary Medicine Cleveland Ohio

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05050591 on ClinicalTrials.gov ↗ ← All trials in the USA