Clinical Trial

A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema

Study acronym: IAB-1
Active, Not Recruiting
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-10-08; most recent amendment 2026-03-11.
Status change: Recruiting → Active, Not Recruiting 2024-01-26
Status change: Not Yet Recruiting → Recruiting 2022-07-15
Trial Details
NCT Number NCT05087641
Lead Sponsor Pulmair Medical, Inc.
Conditions Emphysema, Pulmonary Disease, Chronic Obstructive
Enrollment 20 participants
Start Date 2022-05-03
Primary Completion 2024-03-27 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-13