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Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent
Sponsor: VisionAir Solutions
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.
Official title: Study for Evaluating the Clinical Effectiveness of 3D Printing for a Patient-specific Silicone Stent Airway Implant
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2021-08-05
Completion Date
2025-07
Last Updated
2025-02-05
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (2)
Mayo Clinic
Rochester, Minnesota, United States
Pulmonary Medicine
Cleveland, Ohio, United States