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

Macquarie University, Australia16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Lung SealantDEVICE

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

Endobronchial Valve (EBV)DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * i. 18-85 years of age * ii. Forced Expiratory Volume in 1second (FEV1) 20 - 50% * iii. Residual Volume (RV) \> 175% * iv. 6 min walk test \> 150 m * v. Completed a course of Pulmonary rehabilitation * vi. STRATX assessment - Left Upper Lobe as the most appropriate lobe to target for ELVR * vii. This study will be investigating heterogenous emphysema only. Minimum of 15% differential in emphysema destruction scores at -950 HU Exclusion Criteria: * i. Acute uncontrolled medical illness including ischemic heart disease, cardiac failure, acute renal impairment * ii. Acute respiratory tract infections * iii. Significant bronchiectasis, * iv. Co-existing interstitial lung diseases, pneumothorax, * v. Known active malignancy * vi. Pregnancy.

Locations (1)

Macquarie University

Macquarie Park, New South Wales, Australia

Outcomes

Primary Outcomes

Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-)

Collateral ventilation status will be functionally assessed and confirmed via CHARTIS® System. Examination of left upper lobe to determine percentage of participants converted from collateral ventilation positive to a collateral ventilation negative state

Time frame: 4 weeks post lung sealant application

Secondary Outcomes

Number of participants with improved lung functioning as measured by lung function tests

Lung function will be assessed by spirometry, plethysmography, lung diffusion capacity and capillary blood test

Time frame: 12weeks and 52 weeks post valve implant

Changes Lung volume

Changes in lung volume will be assessed using high resolution computed tomography (HRCT) and target lobe volume reduction (TLVR)

Time frame: 12weeks and 52 weeks post valve implant

Data from ClinicalTrials.gov

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