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A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema
Sponsor: Pulmair Medical, Inc.
Summary
The Pulmair Implantable Artificial Bronchus (IAB) is a device intended for implantation into the diseased bronchi of emphysema patients. The IAB is indicated for bronchoscopic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD)/emphysema to relieve hyperinflation and allow bidirectional ventilation of the affected lobes. The objective of this trial is to demonstrate a suitable benefit/risk profile to support a subsequent trial of the safety and effectiveness of the IAB to achieve its intended purpose. The trial will enroll 24 subjects implanted with IAB(s), at no more than three study centers.
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2022-05-03
Completion Date
2027-01
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
IAB System
Bronchoscopic implantation of one or multiple IABs
Locations (3)
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Thoraxklinik, University of Heidelberg
Heidelberg, Germany
University Medical Center Groningen
Groningen, Netherlands