NCT07119229

A Multi Center Study Testing a New Implant for Adults With Severe Emphysema

A Multicenter, Prospective Trial Evaluating the Safety and Efficacy of the Implantable Artificial Bronchus (IAB) in Adults Suffering From Severe Emphysema

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Pulmair Medical, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

IAB-2 is an open-label (unblinded), multicenter, prospective trial of the Implantable Artificial Bronchus (IAB) in adults suffering from severe COPD/emphysema. There is no control group or comparator. The study will be conducted at as many as twelve sites in the United States and three sites outside of the US, in the Netherlands, Germany and Brazil.

Conditions

• Emphysema or COPD
• Emphysema
• COPD

Interventions

Type	Name	Description
DEVICE	Implantable Artificial Bronchus	The 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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-07-01
• Completion: 2027-11-01
• First posted: 2025-08-13
• Last updated: 2026-03-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study