Silicone Airway Stent for Chronic Obstructive Pulmonary Disease

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VisionAir Solutions

Must not be taking: Anticoagulants

Disqualifiers: Unstable cardiac disease, Silicone allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of silicone airway stent designed specifically for individuals with complex airway diseases, such as chronic obstructive pulmonary disease (COPD). The goal is to develop a stent that lasts longer, fits better, and causes less discomfort than current options. The study will focus on how well these custom-made stents improve symptoms, based on patient-reported experiences. It seeks participants who have experienced temporary relief from previous stents but now face complications, or who need a properly fitting stent. As an unphased trial, this study offers patients a unique opportunity to contribute to the development of a potentially more effective treatment option.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic anticoagulant therapy, it might affect your eligibility for the trial.

What prior data suggests that this method is safe for patients with complex airway disease?

Research has shown that custom-made silicone airway stents are safe and beneficial for people with breathing problems. Created using 3D printing, these stents improve symptoms and require less frequent replacement, reducing the need for medical procedures.

Designed to fit the person's airway precisely, the stents cause less irritation and damage. This personalized fit significantly contributes to their effectiveness. Users have reported an improved quality of life, indicating comfort in use.

In summary, custom-made silicone airway stents have demonstrated promise in being safe and effective, causing fewer problems and increasing user satisfaction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard airway stents for chronic obstructive pulmonary disease (COPD), which are often generic and can be suboptimal, the patient-specific silicone airway stent is tailored to fit the unique airway structure of each patient. This customization aims to improve comfort and effectiveness by directly addressing the patient’s individual anatomy. Researchers are excited about this treatment because it has the potential to significantly alleviate symptoms associated with airway stenosis, improving patient-reported outcomes and quality of life.

What evidence suggests that this patient-specific silicone airway stent is effective for chronic obstructive pulmonary disease?

Research has shown that custom-made silicone airway stents can improve symptoms and reduce the need for frequent replacements in people with complex airway issues. In this trial, participants will receive a patient-specific silicone airway stent, created using 3D printing, to fit each person's airway more precisely. This better fit helps the stents last longer and cause less irritation. Early evidence suggests these stents can improve lung function and offer long-term benefits for people with airway narrowing. Personalized stents seem to be a better treatment option compared to current stents, which have been less effective for this type of airway problem. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults over 22 needing airway stents, who can handle general anesthesia and chest CT scans. They should have a history of temporary relief from existing stents but now face complications or need a custom-sized stent. Expected to live at least 6 months, they must consent, follow up regularly, manage their primary disease at home, and not be on chronic anticoagulants.

Inclusion Criteria

Understand and voluntarily sign an informed consent form

Patients must be able to undergo routine non-contrast CT scans of the chest

I am at least 22 years old.

Exclusion Criteria

Allergy to silicone

I have had a stent placed for blood vessel compression.

I have a long-lasting infection that is resistant to multiple drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Implantation of the patient-specific silicone stent occurs

1 day

1 visit (in-person)

Initial Assessment

Formal assessment for adverse events and initial outcomes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 60, 90, and 180 days

180 days

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Patient-Specific Silicone Airway Stent

Trial Overview The trial is testing patient-specific silicone airway stents designed for individuals with conditions like the common cold or COPD. These custom-made stents aim to last longer, fit better without causing much trauma to the patient's airway.

How Is the Trial Designed?

Group I: Single-Arm Study Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

VisionAir Solutions

Lead Sponsor

Trials

1

Recruited

20+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05050591

Evaluating the Clinical Effectiveness of a Patient-specific ... 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/d28dffd4da61a92a

Evaluating the Clinical Effectiveness of a Patient-specific Silicone ... 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 ...

3. withpower.com withpower.com/trial/phase-pulmonary-disease-chronic-obstructive-7-2021-8fa43

Silicone Airway Stent for Chronic Obstructive Pulmonary Disease Research shows that patient-specific silicone airway stents, created using 3D printing technology, improved symptoms and reduced the need for stent changes in ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0954611124002129

Custom silicone Y-stents for the management of ... Personalized 3D-designed Y-stents demonstrate promising results for managing complicated airway stenosis, offering improved lung function and potential long- ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03111888

Evaluating the Clinical Effectiveness of 3D Printing for a ... The end goal of the project is to create a new patient-specific design that will last longer, fit better, and cause less trauma to the airway and the patient.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10477630/

Patient-specific airway stent using three-dimensional printing A patient-specific stent using 3D printing may minimize complications, improve quality of life, and reduce the need for repeated procedures.