Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion (COVE)

April 25, 2025 updated by: Pulmonx Corporation

A Pilot Study of Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion for Severe Chronic Obstructive Pulmonary Disease (COPD) in Patients With COllateral VEntilation

Prospective, multi-centre, pilot study aimed to evaluate the effect of Video Assisted Thoracic Surgery (VATS) fissure completion on the efficacy of endobronchial valve insertion (Zephyr Valve) in the treatment of subjects with severe Chronic Obstructive Pulmonary Disease (COPD) who exhibit collateral ventilation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will be a prospective, multi-centre, pilot study aimed to evaluate the effect of VATS fissure completion on the efficacy of endobronchial valve insertion (Zephyr Valve) in the treatment of subjects with severe COPD who exhibit collateral ventilation.

Study patients who provide informed consent and meet the initial inclusion/exclusion criteria following baseline screening assessments and multidisciplinary review to determine eligibility will undergo two procedures, not less than 28 days apart. The first procedure will involve an initial bronchoscopy and Chartis® assessment of collateral ventilation under general anaesthesia followed by a VATS fissure completion between targeted lobes in subjects that have collateral ventilation. The second procedure undertaken following fissure completion surgery will involve bronchoscopic insertion of Zephyr® Valve(s) in the targeted lobe, under sedation or general anaesthesia.

Subjects will be followed up over a 6-month period following VATS fissure completion and Zephyr® Endobronchial Valve (Zephyr Valve) insertion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital Melbourne
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Private Hospital Fitzroy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is willing and able to provide informed consent and to participate in the study.
  2. Subject is ≥ 40 years of age.
  3. Subject has a diagnosis of severe or very severe homogenous or heterogeneous COPD (Global Initiative for Obstructive Lung Disease (GOLD) classification).
  4. Subject has a post bronchodilator 15% ≤ FEV1 ≤ 50%.
  5. Subject has Total Lung Capacity (TLC) ≥ 100% predicted.
  6. Subject has Residual Volume (RV) ≥ 150% predicted.
  7. Subject has a normal dobutamine stress echocardiogram.
  8. Subject has sufficient exercise tolerance i.e. 150m ≤ 6MWT ≤ 450m.
  9. Subject has an incomplete lobar fissure i.e. < 90%, as confirmed by CT evaluation of lung fissures.
  10. Collateral ventilation confirmed as assessed by Chartis Assessment (to be confirmed during first procedure/operation)
  11. Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by carboxyhaemoglobin or cotinine levels.
  12. Subject is up to date with preventive vaccinations including seasonal influenza vaccine and pneumococcal vaccine consistent with the Victorian Department of Health and Human Services Immunization Schedule Guidelines (updated March 2018).

Exclusion Criteria:

  1. Subject has a history of previous thoracotomy, lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any form.
  2. Subject has an acute COPD exacerbation.
  3. Subject has evidence of active respiratory infection.
  4. Subject has a post bronchodilator FEV1 < 15%.
  5. Subject has a Diffusing capacity for carbon monoxide (DLCO) < 20%.
  6. Subject has a history of recurrent clinically significant respiratory infections, defined as three (3) or more COPD exacerbations requiring hospitalization during the 12 months prior to study enrollment (Informed Consent Form signature page).

  7. Subject has severe gas exchange abnormalities as defined by any one of the following:

    1. Partial pressure of oxygen (PaO2) < 60 mmHg
    2. Partial pressure of carbon dioxide (PaCO2) > 45 mmHg
    3. Oxygen saturation (SpO2) < 90% on ≥ 4 L/min supplemental O2 at rest
  8. Subject use of systemic steroids > 20mg/day or equivalent and/or immunosuppressive agents in the 4 weeks prior to procedure.
  9. Subject unable to temporarily interrupt use of heparins or oral anticoagulants or antiplatelet agents, excluding aspirin.

  10. Subject's pre-operative CT scan indicates the presence of any of the following radiological abnormalities:

    1. Pulmonary nodule ≥ 0.8 cm in diameter (does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/positron emission tomography (PET)).
    2. Radiological picture consistent with active pulmonary infection, e.g. unexplained parenchymal infiltrate.
    3. Giant bullae > 30% of the volume of either lung.
    4. Significant interstitial lung disease.
    5. Significant pleural disease.
  11. Subject's baseline electrocardiogram (ECG) demonstrates clinically significant arrhythmias or conduction abnormalities.
  12. Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis.
  13. Subject has a known diagnosis of alpha-1 antitrypsin deficiency.
  14. Subject is classified as having "likely" pulmonary hypertension defined as tricuspid regurgitation velocity > 3.4m/s and/or pulmonary artery peak systolic pressure > 45 mmHg on echocardiogram or a previous formal diagnosis of pulmonary hypertension on right heart catheterization.
  15. Subject has suspected significant coronary artery disease defined as regional wall motion abnormalities on dobutamine stress echocardiogram.
  16. Subject is classified as being at major cardiac risk with the presence of unstable coronary syndromes (i.e. unstable or severe angina or recent myocardial infarct), decompensated heart failure, significant arrhythmias or severe valvular disease, which warrants intensive management of the condition in accordance with current guidelines on perioperative cardiovascular risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Patients exhibiting baseline collateral ventilation by Chartis® balloon catheter assessment who undergo video-assisted thoracoscopic surgery (VATS) fissure completion surgery, confirmation of fissure completion by computerized tomography (CT) scan and confirmation of conversion to collateral ventilation negative by Chartis® balloon catheter assessment post VATS surgery and subsequent Zephyr Valve insertion.
Procedure: Video-assisted thoracoscopic surgery (VATS) fissure completion
Following Bronchoscopy and Chartis® balloon catheter assessment under general anaesthesia and confirmation of collateral ventilation, a unilateral VATS lobar fissure completion will be undertaken with buttressed staples and Coseal spray intended to eliminate collateral ventilation.
Device: Zephyr Valve insertion
Following fissure completion surgery, subjects confirmed to be collateral ventilation negative will undergo bronchoscopic insertion of Zephyr® Valve(s) in the targeted lobe, under sedation or general anaesthesia.
Other Names:
  • Bronchoscopic Lung Volume Reduction (BLVR)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Residual Volume (RV)
Time Frame: 6 months
Absolute Change in Residual Volume (RV) from baseline to 6-months post Zephyr Valve procedure.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity (FVC)
Time Frame: 6 months
Absolute change in Forced Vital Capacity (FVC) from baseline to 6-months post Zephyr Valve procedure.
6 months
Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC)
Time Frame: 6 months
Absolute change in FEV1/FVC ratio from baseline to 6-months post Zephyr Valve procedure.
6 months
Total Lung Capacity (TLC)
Time Frame: 6 months
Absolute change in Total Lung Capacity (TLC) from baseline to 6-months post Zephyr Valve procedure.
6 months
Six-Minute Walk Test (6MWT)
Time Frame: 6 months
Absolute change in Six-Minute Walk Test (6MWT) from baseline to 6-months post Zephyr Valve procedure.
6 months
St. George's Respiratory Questionnaire (SGRQ) Total Score
Time Frame: 6 months
Absolute change in the St. George's Respiratory Questionnaire Total Score from Baseline to 6-months post Zephyr Valve procedure. The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.
6 months
Modified Medical Research Council (MMRC) Score
Time Frame: 6 months
Absolute change in the modified Medical Research Council (MMRC) Score from Baseline to 6-months post Zephyr Valve procedure. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.
6 months
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 6 months
Percent change in FEV1 from baseline to 6-months post Zephyr Valve procedure.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pulmonx Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Naveed Alam, MD, St Vincent's Hospital Melbourne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 630-0026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Emphysema

Clinical Trials on Video-assisted thoracoscopic surgery (VATS) fissure completion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings