Silicone Airway Stent for Chronic Obstructive Pulmonary Disease

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VisionAir Solutions

No Placebo Group

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.

Research Team

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.

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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.

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Treatment Details

Interventions

Patient-Specific Silicone Airway Stent (Other)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Single-Arm StudyExperimental Treatment1 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.