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The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR Utilizing Endobronchial Valves.

NCT05396131 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-05-31

No results posted yet for this study

Summary

The aim of this study is to determine the feasibility of combining a lung sealant with endobronchial valves EBV in managing patients with COPD who are collateral ventilation (CV) positive. This study has two arms; arm 1 is for CV positive participants who will receive the lung sealant and EBV; arm 2 is the CV negative group who will only receive EBV as the standard management.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DEVICE

Lung Sealant

The Aeriseal System uses a polymer foam to block or seal fissures, peripheral airways, alveoli, and collateral channels to achieve lung volume reduction.

DEVICE

Endobronchial Valve (EBV)

The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.

Sponsors & Collaborators

  • Macquarie University, Australia

    lead OTHER

Principal Investigators

  • Alvin J Ing, MBBS, MD, FRACP · Clinical Professor and Respiratory Physician

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2022-01-07
Completion
2022-01-07
FDA Device
Yes

Countries

  • Australia

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 NCT05396131 on ClinicalTrials.gov