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

NCT05087641 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-13

No results posted yet for this study

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

DEVICE

IAB System

Bronchoscopic implantation of one or multiple IABs

Sponsors & Collaborators

  • Pulmair Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Hugo Goulart de Oliveira, MD, PhD · Hospital de Clinicas de Porto Alegre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-03
Primary Completion
2024-03-27
Completion
2027-01-31
FDA Device
Yes

Countries

  • Brazil
  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05087641 on ClinicalTrials.gov