NCT05087641

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pulmair Medical, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Emphysema
• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DEVICE	IAB System	Bronchoscopic implantation of one or multiple IABs

Timeline

• Start date: 2022-05-03
• Primary completion: 2024-03-27
• Completion: 2027-01-01
• First posted: 2021-10-21
• Last updated: 2026-03-13

Locations

3 sites across 3 countries: Brazil, Germany, Netherlands

Regulatory

• FDA-regulated device study