An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema
Recruiting · 36 sites across 21 states
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Study care at no cost to you
For your time and travel
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Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
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Your choice
Voluntary — you can stop anytime
What is this study?
This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV- status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic lung volume reduction (BLVR) and be followed for 24 months.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Age 40 to 80 years old (at the time the informed consent form is signed).
- •Has completed a pulmonary rehabilitation program in the 12 months before starting the study.
- •Stopped smoking at least 8 weeks before the consent form is signed (checked by blood/urine tests).
- •Has severe emphysema with specific scan (HRCT) findings in the treatment lung area and meets required breathing/lung-function test ranges.
- •Has collateral ventilation confirmed as present (CV+) using the Chartis assessment before the AeriSeal procedure.
🚫 You may not be able to join if…
- •Has had certain prior lung procedures (like lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, airway stent, pleurodesis, or BLVR), with a specific exception related to Zephyr Valve and timing.
- •Has certain major CT/HRCT scan problems, such as a lung nodule over 0.8 cm or active lung infection, unless specific “stable/benign” situations apply.
- •Has asthma as the primary diagnosis, or chronic bronchitis as the primary diagnosis, or clinically significant bronchiectasis.
- •Has severe breathing/oxygen or carbon dioxide problems at rest (PaO2 < 45 mm Hg or PaCO2 ≥ 50 mm Hg).
- •Is pregnant, breastfeeding, or planning pregnancy in the next 12 months, or has BMI < 18 or BMI > 35.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 40–80
- ✓Have COPD (chronic lung disease)
- !Some conditions may not be a fit: Obesity / overweight, Heart / cardiovascular disease, High blood pressure, Asthma
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
What you need to know before you apply
What is this study testing?+
This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System.
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT06035120 · Locations: Arizona · Connecticut · Florida · Illinois · Massachusetts · Michigan · Ohio · Pennsylvania · Tennessee · Texas · Virginia · Wisconsin · Australia · Austria · Denmark · France · Germany · Italy · Netherlands · Spain · England