What is the Implantable Artificial Bronchus 50 Flex studying for severe emphysema?

This trial is studying the safety and effectiveness of the Implantable Artificial Bronchus 50 Flex implant in adults with severe COPD or emphysema. Researchers want to understand how well this device works to support lung function in patients with these conditions. The study is sponsored by Pulmair Medical, Inc.

Who may be eligible for this severe emphysema clinical trial?

Adults aged 22 years or older with a diagnosis of COPD or emphysema may be eligible. Participants must be non-smokers for at least 4 months, have a BMI between 18 and 32, and be able to walk 100 to 400 meters in 6 minutes. Please review eligibility criteria for more details.

Is there any cost to participate in this severe emphysema clinical trial?

Study-related care, including the implant procedure and all trial visits, is provided at no cost. However, personal travel expenses or other costs related to participation may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 22Years +

All Genders

ID07086339

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

Led by Pulmair Medical, Inc. · Updated on 2026-06-03

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Implantable Artificial Bronchus 50 Flex IAB 50 Flex, a new implant for adults who have severe COPD or emphysema. This trial is conducted at two hospitals and aims to study the implants impact on patients with these serious lung conditions. The study is sponsored by Pulmair Medical, Inc. and does not involve masking or blinding. Participants will undergo one or two procedures to place up to 10 polymer-based IAB implants in one or both lungs. These implants are designed to support the lungs affected by COPD or emphysema. The trial involves only the treatment group receiving the implant, with no comparison to placebo or other treatments. During the study, participants will be monitored for safety, focusing on the incidence of serious adverse events within 90 days after the last implant procedure. Researchers will assess lung function and disease stability through various tests and clinical evaluations. The study starts in February 2026 and will continue through December 2027, with participants undergoing screening and follow-up visits to evaluate treatment effects and overall health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 22Years +

All Genders

Eligibility Criteria

You may qualify if you...

Signed Informed Consent
Diagnosis of COPD or emphysema
At least 22 years of age
Body mass index (BMI) between 18 and 32
6-minute walk distance between 100 and 400 meters
Stable disease with less than 10 mg prednisone (or equivalent) daily
Non-smoking for at least 4 months prior to screening
FEV1 between 15% and 45% of predicted value at baseline
FEV1/FVC less than 70%
Emphysema destruction score of at least 25% in each lung by CT scan
Homogeneous or heterogeneous emphysema with at least 15% difference between lobes
Residual volume (RV) greater than 175% of predicted value
mMRC score of 2 or higher

You will not qualify if you...

Currently participating in another clinical study involving surgery, interventional or pharmaceutical treatment
Alpha-1 antitrypsin deficiency
Women of child-bearing potential
More than 2 COPD exacerbations requiring hospitalization in the past year
COPD exacerbations requiring hospitalization within 6 weeks prior to intervention
Two or more pneumonia episodes requiring hospitalization in the past year
Clinically significant mucus production or chronic bronchitis
Recent myocardial infarction or unstable/uncontrolled congestive heart failure within 6 months
Prior lung transplant, lung volume reduction surgery, bullectomy, lobectomy, or endoscopic lung volume reduction
Clinically significant bronchiectasis
Unable to safely stop anti-coagulants or platelet inhibitors for 7 days
Uncontrolled pulmonary hypertension or history of cor pulmonale
Suspected lung cancer or malignant pulmonary nodule
Large bullae encompassing more than 30% of either lung on recent CT scan
Insufficient landmarks for CT evaluation
All lobes with less than 25% diseased lung tissue
Any cardiac condition deemed unsafe for IAB implant by investigator
Total lung capacity less than 100% predicted
DLCO less than 15% or greater than 50% predicted
PaCO2 greater than 50 mm Hg at screening
PaO2 less than 45 mm Hg in room air at screening
Plasma cotinine level greater than 13.7 ng/ml or carboxyhemoglobin over 2.5%
Current diagnosis of substance abuse disorder
Diagnosis of major depressive disorder, schizoaffective disorder, schizophrenia, borderline personality disorder, or bipolar disorder
Any other condition that would make participation unsuitable or interfere with study completion as determined by the investigator

Research Team

VP Clinical Operations

Clinical Study Manager

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here