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

  • STATUS
    Recruiting
  • End date
    Jun 17, 2023
  • participants needed
    20
  • sponsor
    VisionAir Solutions
Updated on 20 October 2022

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.

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.

Details
Condition Pulmonary Disease, Chronic Obstructive
Treatment Patient-Specific Silicone Airway Stent
Clinical Study IdentifierNCT05050591
SponsorVisionAir Solutions
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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