RecruitingNot ApplicableNCT07086339

A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema

A Two Center Trial of the Implantable Artificial Bronchus 50 Flex (IAB 50 Flex) in Patients With Severe Emphysema


Sponsor

Pulmair Medical, Inc.

Enrollment

20 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new implantable device called the Artificial Bronchus 50 Flex for people with severe emphysema (a type of COPD where lung tissue is progressively destroyed). The device is placed inside airways to help redirect airflow and improve breathing without major surgery. **You may be eligible if...** - You are at least 22 years old - You have been diagnosed with COPD or emphysema - Your BMI is between 18 and 32 - You can walk 100 to 400 meters in a 6-minute walk test - You have not smoked for at least 4 months prior to enrollment - Your lung function tests show significant airflow obstruction (FEV1 between 15% and 45% of expected) - CT scans show significant emphysema destruction in both lungs **You may NOT be eligible if...** - You have had recent COPD hospitalizations or flare-ups - You have pulmonary hypertension or other serious lung conditions - You have had prior lung surgery or bronchoscopy procedures for emphysema - You take more than 10 mg of prednisone daily Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEImplantable pulmonary stent

Implantable polymer based pulmonary stent for severe COPD/emphysema


Locations(2)

DUPUYTREN University Hospital

Limoges, France

University Medical Center Groningen

Groningen, Netherlands

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NCT07086339


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