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ACTIVE NOT RECRUITING
NCT05050591
NA

Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

Sponsor: VisionAir Solutions

View on ClinicalTrials.gov

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

Interventions

DEVICE

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