Implant for Emphysema
(IAB-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for individuals with severe COPD/emphysema, focusing on its effectiveness and safety. Participants will receive an Implantable Artificial Bronchus, a stent-like device placed in the lungs to aid breathing. The trial suits those diagnosed with COPD/emphysema who struggle with walking long distances or have recently quit smoking. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research and potentially enhance quality of life.
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you must be able to safely stop taking anti-coagulants or platelet activity inhibitors for 7 days.
What prior data suggests that this implant is safe for treating emphysema?
Research has shown that the Implantable Artificial Bronchus (IAB) has undergone safety testing in people with emphysema. In one study, the IAB's safety improved over time as adjustments were made. Another study found that about 21.7% of patients experienced at least one serious side effect related to the device within six months, including pneumonia, which affected 10% of participants.
The main goal of these studies was to assess safety by monitoring serious side effects, particularly those affecting breathing. Although some patients experienced complications, the studies aimed to enhance the device's safety over time. Overall, while the IAB shows promise, risks remain, and ongoing research continues to improve its safety for treating emphysema.12345Why are researchers excited about this trial?
The Implantable Artificial Bronchus (IAB) is unique because it offers a new approach to treating emphysema by using polymer-based stents that can be permanently placed in the diseased parts of the lungs. Unlike traditional treatments like medications, oxygen therapy, or surgery, which aim to manage symptoms or remove damaged tissue, the IAB directly enhances airflow by physically opening airways. Researchers are excited about this treatment because it could provide long-lasting relief for patients by maintaining lung function and improving breathing more effectively than current options.
What evidence suggests that the Implantable Artificial Bronchus is effective for emphysema?
Studies have shown that the Implantable Artificial Bronchus can significantly aid people with severe emphysema. In one study, most patients who received the implant experienced noticeable improvements in breathing. Another study found that the implant reduced the problem of air trapping in the lungs. Regarding safety, most implants did not cause blockages or other serious issues in patients over a 90-day period. These findings suggest that the implant could be a promising option for those struggling with emphysema. In this trial, all participants will receive treatment with the Implantable Artificial Bronchus.13456
Who Is on the Research Team?
Adnan Majid, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
This trial is for adults aged 22 or older with severe COPD/emphysema who have stopped smoking (including vaping and marijuana) for at least 4 months. Participants must be able to walk between 100-400 meters in six minutes, have stable disease, specific lung function test results, and a certain amount of emphysema seen on CT scans.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment with a maximum of 10 Implantable Artificial Bronchus (IABs)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in pulmonary function and adverse device effects
What Are the Treatments Tested in This Trial?
Interventions
- Implantable Artificial Bronchus
Trial Overview
The study is testing a new device called the Implantable Artificial Bronchus in people with severe emphysema/COPD. The goal is to see how well this implant works and how safe it is across several centers in the US, Europe, and Brazil.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All subjects will receive treatment with a maximum of 10 Implantable Artificial Bronchus (IABs) which are polymer based stents that can be permanently placed in any diseased lobe of the lungs.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pulmair Medical, Inc.
Lead Sponsor
Citations
First-In-Human Trial of the Implantable Artificial Bronchus
... COPD exacerbation, and pneumothorax. The majority of patients improved clinically with statistically significant outcomes in all effectiveness ...
Implantable Artificial Bronchus (IAB) Performance up to 1 year
Results: No obstruction or granuloma were observed in 77% (20/26) IABs at 30-days and in 79% (30/38) IABs at 90-days. Endpoint RV reduction exceeded the MCID (≤ ...
3.
iris-purple-syew.squarespace.com
iris-purple-syew.squarespace.com/s/Poster_ats_2024_IAB_Trial-1_version_May10-final-Open.pdfA Multicenter, Prospective Trial Of The Implantable Artificial ...
A. Prototype Implantable Artificial Bronchus Reduces Lung. Hyperinflation in Recently Deceased Patients with Emphysema. Respiration. 2023;102(2):154-163. 33. 73.
A Prototype Implantable Artificial Bronchus Reduces Lung ...
Results: IAB implantation significantly reduced Pplat,rs (p = 0.017) in 6 of 7 deceased patients with emphysema and iPEEP (p = 0.03) in 5 of 7 ...
First-In-Human Trial of the Implantable Artificial Bronchus
The majority of patients improved clinically with statistically significant outcomes in all effectiveness variables (residual volume, six-.
A Trial of the Implantable Artificial Bronchus 50 Flex in ...
There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...
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