A Multi Center Study Testing a New Implant for Adults With Severe Emphysema
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Pulmair Medical, Inc.
- Study ID
- NCT07119229
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Implantable Artificial Bronchus — DEVICEThe Implantable Artificial Bronchus (IAB) is a tapered, flexible and fenestrated polymer-based airway stent that is implanted bronchoscopically using a proprietary delivery system into diseased lungs of patients with emphysema.
Study Details
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.
Key Dates
- Start date
- Mar 25, 2026
- Status verified
- Jun 2026
- Primary completion
- Jul 31, 2027
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: All subjects will receive study treatmentAll 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.
Primary Outcome Measure
Absolute change in residual volume (RV) [ Time Frame: 90 days after last IAB is implanted ]
Central Contacts
- VP Clincal Operations858-369-0000
- Clinical Study Manager858-369-0000
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | Eric Seeley, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern University | Chicago | Illinois | 60611 | Momen M Wahidi, MD, MBA (PRINCIPAL_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Adnan Majid, MD (PRINCIPAL_INVESTIGATOR) |
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