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Completed

NCT Number: NCT05396131

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Macquarie University

Macquarie Park, New South Wales, 2109, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung Sealant

Device

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

Other names: AeriSeal

Endobronchial Valve (EBV)

Device

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

Other names: Zephyr Endobronchial Valve System

Primary outcomes

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

    Time frame: 4 weeks post lung sealant application

    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

Secondary outcomes

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

    Time frame: 12weeks and 52 weeks post valve implant

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

  2. Changes Lung volume

    Time frame: 12weeks and 52 weeks post valve implant

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

Sponsors and collaborators

Lead sponsor

Macquarie University, Australia

Other

Registry information

Official study title

The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR (Endoscopic Lung Volume Reduction) Utilizing Endobronchial Valves

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 31, 2022
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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