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

NCT05087641 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IAB1-CIP
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

Bronchoscopic Lung Volume Reduction (BLVR)

Outcome Measures

Primary Outcomes (1)

• Safety - Incidence of respiratory serious adverse events (SAEs)

  The primary endpoint is the occurrence of respiratory SAEs: * Acute asthma/bronchospasm requiring intensive/critical care unit admission * Acute COPD exacerbation (is acute onset, life-threatening, requires hospitalization) * Airway injury from IAB placement/migration/airway stenosis requiring surgical intervention * Death from procedure/IAB * Massive hemoptysis (est. \>100 ml in 24hr requiring transfusion, surgery, or arterial embolization) from procedure/IAB * Pneumonia in treated lobe requiring hospitaliz., IV antibiotics, IAB removal * Pneumonia NOT in treated lobe (is life-threatening, acute onset, requires hospitaliz. \& IV antibiotics) * Pneumothorax requiring surgery * Tension pneumothorax (is life-threatening, acute onset, requires hospitaliz. \& treatment) * Respiratory failure requiring mechanical ventilatory support \>24hr A thoracic SAE composite, based on number of subjects experiencing a thoracic SAE, will also be calculated and tabulated.

  From baseline to 90 days post implant (for endpoint evaluation)

Secondary Outcomes (14)

• Safety - Incidence of other serious adverse device effects (SADEs)

  From baseline to 90 days post implant (for endpoint evaluation)

• Efficacy - Residual Volume (RV), absolute change

  From baseline to 90 days post implant (for endpoint evaluation)

• Efficacy - Residual Volume (RV), percent change

  From baseline to 90 days post implant (for endpoint evaluation)

• Efficacy - Forced Expiratory Volume in one second (FEV1), absolute change

  From baseline to 90 days post implant (for endpoint evaluation)

• Efficacy - Forced Expiratory Volume in one second (FEV1), percentage change

  From baseline to 90 days post implant (for endpoint evaluation)

Study Arms (1)

IAB System

EXPERIMENTAL

Patients will be treated with IAB(s)

Device: IAB System

Interventions

IAB System DEVICE

Bronchoscopic implantation of one or multiple IABs

IAB System

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• Diagnosis of COPD/emphysema
• Age 40 to 75 years
• Body Mass Index (BMI) less than 30 kg/m2
• minute walk Distance between 100 meters and 500 meters at baseline exam
• Stable disease with less than 10 mg prednisone (or equivalent) daily
• Non-smoking for 4 months prior to screening interview
• FEV1 between 15% and 50% of predicted value at baseline exam
• FEV1/Forced Vital Capacity (FVC) \< 70%
• RV \> 175%
• mMRC score ≥ 2

You may not qualify if:

• Currently participating in another clinical study
• Women of child-bearing potential
• More than 2 COPD exacerbation episodes requiring hospitalization in the last year at screening
• Any COPD exacerbations within 6 weeks of planned intervention
• Two or more instances of pneumonia episodes in the last year at screening
• Clinically significant mucus production or chronic bronchitis
• Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6 months of screening
• Prior lung transplant, Lung Volume Reduction Surgery (LVRS), bullectomy or lobectomy
• Clinically significant bronchiectasis
• Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7 days
• Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \> 45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram (completed within the last 3 months prior to screening visit)
• Suspected pulmonary nodule or lung cancer
• High Resolution Computed Tomography (HRCT) collected per CT scanning protocol within the last 6 months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:
• Large bullae encompassing greater than 30% of either lung
• Insufficient landmarks to evaluate the CT study using the software as it is intended

Sponsors & Collaborators

• Pulmair Medical, Inc.: lead

Study Sites (3)

Hospital de Clinicas de Porto Alegre

Porto Alegre, CEP 90035-003, Brazil

Location

Thoraxklinik, University of Heidelberg

Heidelberg, D-69126, Germany

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Officials

• Hugo Goulart de Oliveira, MD, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label (unblinded), multicenter, prospective trial of the Implantable Artificial Bronchus (IAB) in adults suffering from COPD/emphysema. There is no control group or comparator.

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 21, 2021
• Study Start: May 3, 2022
• Primary Completion: March 27, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); DE (1); BR (1)