RecruitingNot Applicable

A Multi Center Study Testing a New Implant for Adults With Severe Emphysema

United States60 participantsStarted 2026-03-25

Plain-language summary

A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.

Who can participate

Age range

22 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

. Signed Informed Consent.
. Diagnosis of COPD/emphysema.
. At least 22-years of age.
. 18 ≤ BMI ≤ 32.
. 6-minute walk Distance between 100-meters and 400-meters at baseline exam.
. Stable disease with less than 10-mg prednisone (or equivalent) daily
. Non-smoking for 4-months prior to screening interview (including tobacco, vaping, marijuana, etc.).
. FEV1 between 15% and 50% of predicted value at baseline exam.

Exclusion criteria

. Large bullae encompassing greater than 30% of either lung
. Insufficient landmarks to evaluate the CT study using the software as it is intended
. All lobes are less than 25% parenchyma diseased (\< -950 HU) 15. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant.

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.

What they're measuring

Absolute change in residual volume (RV)

Timeframe: 90 days after last IAB is implanted

Trial details

NCT IDNCT07119229

SponsorPulmair Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

VP Clincal Operations

858-369-0000 tkruger@pulmair.com

View on ClinicalTrials.gov More Emphysema or COPD trials