Pulmonary EmphysemaCOVENCT04465461
Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion
A study testing Video-assisted thoracoscopic surgery (VATS) fissure completion and Zephyr Valve insertion in people with Pulmonary Emphysema, run by Pulmonx Corporation at 2 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Emphysema
- What is being tested?
- Video-assisted thoracoscopic surgery (VATS) fissure completion and Zephyr Valve insertion
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesAustralia
- Study dates
- 4 Jun 2020to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is willing and able to provide informed consent and to participate in the study.
- Subject is ≥ 40 years of age.
- Subject has a diagnosis of severe or very severe homogenous or heterogeneous COPD (Global Initiative for Obstructive Lung Disease (GOLD) classification).
- Subject has a post bronchodilator 15% ≤ FEV1 ≤ 50%.
- Subject has Total Lung Capacity (TLC) ≥ 100% predicted.
- Subject has Residual Volume (RV) ≥ 150% predicted.
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- Subject has a normal dobutamine stress echocardiogram.
- Subject has sufficient exercise tolerance i.e. 150m ≤ 6MWT ≤ 450m.
- Subject has an incomplete lobar fissure i.e. < 90%, as confirmed by CT evaluation of lung fissures.
- Collateral ventilation confirmed as assessed by Chartis Assessment (to be confirmed during first procedure/operation)
- Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by carboxyhaemoglobin or cotinine levels.
- 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).
Who cannot join
- 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.
- Subject has an acute COPD exacerbation.
- Subject has evidence of active respiratory infection.
- Subject has a post bronchodilator FEV1 < 15%.
- Subject has a Diffusing capacity for carbon monoxide (DLCO) < 20%.
- 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).
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- Subject has severe gas exchange abnormalities as defined by any one of the following:
- Partial pressure of oxygen (PaO2) < 60 mmHg
- Partial pressure of carbon dioxide (PaCO2) > 45 mmHg
- Oxygen saturation (SpO2) < 90% on ≥ 4 L/min supplemental O2 at rest
- Subject use of systemic steroids > 20mg/day or equivalent and/or immunosuppressive agents in the 4 weeks prior to procedure.
- Subject unable to temporarily interrupt use of heparins or oral anticoagulants or antiplatelet agents, excluding aspirin.
- Subject's pre-operative CT scan indicates the presence of any of the following radiological abnormalities:
- 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)).
- Radiological picture consistent with active pulmonary infection, e.g. unexplained parenchymal infiltrate.
- Giant bullae > 30% of the volume of either lung.
- Significant interstitial lung disease.
- Significant pleural disease.
- Subject's baseline electrocardiogram (ECG) demonstrates clinically significant arrhythmias or conduction abnormalities.
- Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis.
- Subject has a known diagnosis of alpha-1 antitrypsin deficiency.
- 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.
- Subject has suspected significant coronary artery disease defined as regional wall motion abnormalities on dobutamine stress echocardiogram.
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
St. Vincent's Private Hospital Fitzroy
Fitzroy, Victoria, 3065
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Emphysema
- Being tested
- Video-assisted thoracoscopic surgery (VATS) fissure completion, Zephyr Valve insertion
- Medical subject headings
- Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-assisted thoracoscopic surgery (VATS) fissure completionProcedure or surgery
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.
Zephyr Valve insertionDevice
Also called Bronchoscopic Lung Volume Reduction (BLVR)
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Procedure: Video-assisted thoracoscopic surgery (VATS) fissure completion; Device: Zephyr Valve insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Volume (RV)
Absolute Change in Residual Volume (RV) from baseline to 6-months post Zephyr Valve procedure.
Measured: 6 months
Secondary outcomes (7)
Forced Vital Capacity (FVC)
Absolute change in Forced Vital Capacity (FVC) from baseline to 6-months post Zephyr Valve procedure.
Measured: 6 months
Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC)
Absolute change in FEV1/FVC ratio from baseline to 6-months post Zephyr Valve procedure.
Measured: 6 months
Total Lung Capacity (TLC)
Absolute change in Total Lung Capacity (TLC) from baseline to 6-months post Zephyr Valve procedure.
Measured: 6 months
Six-Minute Walk Test (6MWT)
Absolute change in Six-Minute Walk Test (6MWT) from baseline to 6-months post Zephyr Valve procedure.
Measured: 6 months
St. George's Respiratory Questionnaire (SGRQ) Total Score
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.
Measured: 6 months
Modified Medical Research Council (MMRC) Score
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.
Measured: 6 months
Forced Expiratory Volume in 1 second (FEV1)
Percent change in FEV1 from baseline to 6-months post Zephyr Valve procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start4 Jun 2020
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmonx Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naveed Alam, MD, Principal investigator, St Vincent's Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465461
- Sponsor's protocol ID
- 630-0026-01
- Acronym
- COVE
- Status last verified
- Apr 2025
- First submitted
- 7 Jul 2020
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04465461
- Acronym / sponsor ID
- COVE / 630-0026-01
- Conditions
- Pulmonary Emphysema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Pulmonx CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Video-assisted thoracoscopic surgery (VATS) fissure completion, Device: Zephyr Valve insertionPatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is willing and able to provide informed consent and to participate in the study.
- Subject is ≥ 40 years of age.
- Subject has a diagnosis of severe or very severe homogenous or heterogeneous COPD (Global Initiative for Obstructive Lung Disease (GOLD) classification).
- Subject has a post bronchodilator 15% ≤ FEV1 ≤ 50%.
- Subject has Total Lung Capacity (TLC) ≥ 100% predicted.
Key exclusion criteria (24 listed)
- 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.
- Subject has an acute COPD exacerbation.
- Subject has evidence of active respiratory infection.
- Subject has a post bronchodilator FEV1 < 15%.
- Subject has a Diffusing capacity for carbon monoxide (DLCO) < 20%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-assisted thoracoscopic surgery (VATS) fissure completionFollowing 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. | Procedure or surgery | Treatment |
| Zephyr Valve insertionAlso: Bronchoscopic Lung Volume Reduction (BLVR)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. | Device | Treatment |
Primary outcome
Residual Volume (RV)
Time frame: 6 months
Absolute Change in Residual Volume (RV) from baseline to 6-months post Zephyr Valve procedure.
7 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: 6 months
Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC)
Time frame: 6 months
Total Lung Capacity (TLC)
Time frame: 6 months
Six-Minute Walk Test (6MWT)
Time frame: 6 months
St. George's Respiratory Questionnaire (SGRQ) Total Score
Time frame: 6 months
Modified Medical Research Council (MMRC) Score
Time frame: 6 months
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveed Alam, MD principal investigator
St Vincent's Hospital Melbourne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-assisted thoracoscopic surgery (VATS) fissure completion and Zephyr Valve insertion in people with Pulmonary Emphysema, run by Pulmonx Corporation at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual Volume (RV) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.