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 range22 Years

SexALL

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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.

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