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ACTIVE NOT RECRUITING
NCT05087641
NA

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

Sponsor: Pulmair Medical, Inc.

View on ClinicalTrials.gov

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

DEVICE

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