Silicone Airway Stent for Chronic Obstructive Pulmonary Disease

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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Patient-Specific 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 patients with complex airway diseases over a year. This suggests that such customized stents can be effective in managing airway issues by providing a better fit and durability. ^{1 2 3 4 5}

How is the Patient-Specific Silicone Airway Stent treatment different from other treatments for COPD?

The Patient-Specific Silicone Airway Stent is unique because it is custom-made for each patient using 3D printing technology, ensuring a better fit in the airway compared to standard stents. This personalized approach can lead to improved durability, shorter procedure times, and fewer complications, as seen in patients with other airway diseases. ^{1 3 4 5 6}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. Japan pubmed.ncbi.nlm.nih.gov

Long-term survival of airway silicone stents in patients with central airway stenosis or obstruction due to thoracic malignancy. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Silicone stents in the management of inoperable tracheobronchial stenoses. Indications and limitations. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A dedicated tracheobronchial stent. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Application of 3D Printing for Patient-Specific Silicone Stents: 1-Year Follow-Up on 2 Patients. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A Silastic stent for palliation of extrinsic tracheal compression or unresectable tracheobronchial obstruction. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical and laboratory evaluation of a new thin-walled self-expanding tracheobronchial silicone stent: progress and pitfalls. [2004]