NCT05050591

Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

Study for Evaluating the Clinical Effectiveness of 3D Printing for a Patient-specific Silicone Stent Airway Implant

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: VisionAir Solutions · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective trial of the clinical utility of a patient-specific silicone stent implant for patients with complex airway disease, requiring an airway stent. The aim of this study is to observe the outcomes associated with the implants. Current stents have been suboptimal for treating benign stenosis of the airway and we are seeking to create a better treatment option. We hypothesize, based on the previous compassionate-use cases, that placing a patient-specific silicone stent will effectively alleviate symptoms associated with stenosis of the airway. The main measure of effectiveness will be patient-reported outcomes. The implant will occur on Day 0 and TDI and formal assessment for AEs will occur on Day 1. Patients will be seen on Day 60 +/- 14 days for formal assessment including TDI and QOL, dynamic CT, and a bronchoscopy procedure will be performed as per our usual standard of care. Additional ascertainments of the TDI and QOL measurements will occur at 90 and 180 days after implantation. A standardized assessment of the stent as well and any modification or any other treatments will be recorded. Washing for cultures will also be done per standard of care during any bronchoscopy.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-05
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2021-09-20
• Last updated: 2025-02-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study