Airway Bypass - Safety and Feasibility Study (NCT06249529) | Clinical Trial Compass
UnknownEarly Phase 1
Airway Bypass - Safety and Feasibility Study
Georgia10 participantsStarted 2024-01-26
Plain-language summary
The objective of this study is to evaluate its safety and feasibility of the Airway Bypass Stent System in patients with severe emphysema. The study will collect clinical data through 12 months to assess procedural and device safety.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient between 50 to 80 years old.
. High Resolution CT scan indicates severe emphysema.
. Patient has post- bronchodilator FEV1 less than or equal to 50% of predicted.
. Total Lung Capacity \>100% of predicted.
. Residual volume ≥225 % of predicted.
. RV/TLC \>0.69
. Patient has marked dyspnea scoring \>2 on mMRC scale of 0-4.
. Patient has stopped smoking for a minimum of 8 weeks prior to entering the study, as confirmed by COHb ≤2.5%.
Exclusion criteria
. Patient has clinically significant sputum production.
. Patient has a change in FEV1 \>20% post-bronchodilator.
. Patient has a history of recurrent clinically significant respiratory infection, defined as with more than 3 hospital stays in the past 12 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure \>50mmHg and/or evidenced by echocardiogram.
. Patient has an inability to walk less than 140 meters (150 yards) or greater than 450 meters in 6 minutes.
. Patient has evidence of any other disease that may compromise survival such as lung cancer, renal failure, any other investigator identified diseases.
. Patient has an inability to tolerate bronchoscopy under anesthesia.
. Any contraindication to bronchoscopy procedure, including but not limited to: