Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: Patient-Specific Silicone Airway Stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-Arm Study<br>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. | Device: Patient-Specific Silicone Airway Stent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Dyspnea Index/Transitional Dyspnea Index | Change in BDI/TDI over course of study | Day -1 | 
| Baseline Dyspnea Index/Transitional Dyspnea Index | Change in BDI/TDI over course of study | Day 1 | 
| Baseline Dyspnea Index/Transitional Dyspnea Index | Change in BDI/TDI over course of study | Day 14 | 
| Baseline Dyspnea Index/Transitional Dyspnea Index | Change in BDI/TDI over course of study | Day 30 | 
| Baseline Dyspnea Index/Transitional Dyspnea Index | Change in BDI/TDI over course of study | Day 60 | 
| Baseline Dyspnea Index/Transitional Dyspnea Index | Change in BDI/TDI over course of study | Day 90 | 
| Baseline Dyspnea Index/Transitional Dyspnea Index | Change in BDI/TDI over course of study | Day 180 | 
| Ability to implant stent | Number of patients able to successfully receive patient-specific stent | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SGRQ | Change in Quality of Life over course of study | Day -1 | 
| SGRQ | Change in Quality of Life over course of study | Day 60 | 
| SGRQ | Change in Quality of Life over course of study | Day 90 | 
| SGRQ | Change in Quality of Life over course of study | Day 180 | 
| CTCAE | Number of adverse event(s) over course of study | Day 0 | 
| CTCAE | Number of adverse event(s) over course of study | Day 1 | 
| CTCAE | Number of adverse event(s) over course of study | Day 14 | 
| CTCAE | Number of adverse event(s) over course of study | Day 30 | 
| CTCAE | Number of adverse event(s) over course of study | Day 60 | 
| CTCAE | Number of adverse event(s) over course of study | Day 90 | 
| CTCAE | Number of adverse event(s) over course of study | Day 180 |