EmphysemaCONVERTNCT04559464
Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status (CONVERT)
A study testing AeriSeal and Zephyr Valves in people with Emphysema and COPD, run by Pulmonx Corporation at 14 sites in 7 countries.
Trial summary
This is a prospective, open-label, multi-center, single-arm study to be conducted at up to 20 investigational sites. The Study plans to enroll up to 140 subjects with severe emphysema and collateral ventilation in the target lobe. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Emphysema, COPD, Severe Emphysema
- What is being tested?
- AeriSeal and Zephyr Valves
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 14 sitesin 7 countries
- Study dates
- 15 Dec 2020to 21 Oct 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 to 75 years
- 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 and ≤ 75 years of age at the time Informed Consent signature.
- Subject has at least one lobe with ≥ 50% emphysema destruction (at -910 HU) as determined by QCT.
- Subject has a diagnosis of homogenous or heterogeneous emphysema, confirmed by HRCT scan. Heterogeneous emphysema defined as ≥ 15% difference (at -910 HU) in emphysema destruction score of adjacent lobes by HRCT.
- Subject has a gap in the interlobar fissure that corresponds to one or more segments as determined by QCT.
- Subject has clinically significant dyspnea with a mMRC Dyspnea score ≥ 2.
Show all 12Show fewer
- Subject has a Six-Minute Walk Distance ≥ 250 meters.
- Subject has post-bronchodilator FEV1 ≥ 15% predicted and ≤ 50% predicted.
- Subject has post-bronchodilator Total Lung Capacity ≥ 100% predicted.
- Subject has post-bronchodilator Residual Volume ≥ 150% predicted if heterogeneous emphysema and ≥ 200% predicted if homogeneous emphysema.
- Subject has stopped smoking for at least eight (8) weeks prior to Screening visit as confirmed by carboxyhemoglobin or cotinine levels.
- Subject has received preventive vaccinations against potential respiratory infections consistent with local recommendations or policy.
Who cannot join
- Subject has severe bullous emphysema where bulla is ≥ 1/3 of the total lung volume.
- Subject has had prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior ipsilateral pleurodesis, or prior endobronchial lung volume reduction therapy of any type.
- Subject has evidence of active respiratory infection.
- Subject has an ongoing COPD exacerbation or bronchospasm.
- Subject has a known allergy to the device components:
- Polyether block amide - PEBAX®
Show all 50Show fewer
- Polyvinyl Alcohol
- Glutaraldehyde
- Nitinol (nickel-titanium) or its constituent metals (nickel or titanium)
- Silicone
- Subject requires invasive ventilatory support (NOTE: The use of continuous Positive Airway Pressure (CPAP) and BiPAP devices for Sleep Apnea is permitted).
- Subject has post-bronchodilator Diffusion Capacity (DLCO) < 20% predicted.
- Subject cannot tolerate corticosteroids or relevant antibiotics.
- Subject has other relevant comorbidities as judged by the Investigator or is deconditioned and cannot tolerate the stress of post-treatment inflammatory response.
- Subject has had three (3) or more COPD exacerbations requiring hospitalization during the year prior to Informed Consent signature.
- Subject has severe gas exchange abnormalities as defined by any one of the following (test conducted at rest on room air as tolerated, or on up to 4 L/min supplemental O2):
- PaCO2 ≥ 55 mm Hg (7.3 kPa)
- PaO2 < 45 mm Hg (6.0 kPa)
- SpO2 < 90%
- Subject has uncontrolled pulmonary hypertension, defined as peak pulmonary systolic pressure > 45 mm Hg on echocardiogram or right heart catheterization.
- Subject use of systemic steroids > 20 mg/day prednisolone or equivalent within 4 weeks of Informed Consent signature.
- Subject use of immunosuppressive agents within four (4) weeks of Informed Consent signature.
- Subject whose use heparins and oral anticoagulants (e.g., warfarin, dicumarol) cannot be discontinued according to local pre-procedural protocols. Note: antiplatelet drugs including aspirin and clopidogrel are permitted.
- Subject's CT scan indicates the presence of any the following radiologic abnormalities:
- Pulmonary nodule on CT scan greater than 0.8 cm in diameter (Does not apply if present for one (1) year or more without increase in size or if proven benign by biopsy).
- Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate.
- Significant interstitial lung disease.
- Significant pleural disease.
- Subject's baseline EKG indicates non-atrial arrhythmias or conduction abnormalities.
- Subject has high cardiac risk after undergoing cardiac risk assessment in accordance with published guidelines or ischemic heart disease, congestive heart failure, renal failure, or cerebrovascular disease.
- Subject has clinically significant asthma (reversible airway obstruction), chronic bronchitis, or bronchiectasis.
- Subject has allergy or sensitivity to medications required to safely perform bronchoscopy under conscious sedation or general anesthesia.
- Subject participated in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to Screening visit. Subjects being followed as part of a long-term surveillance of a non-pulmonary study that has reached its primary endpoint are eligible for participation in this study.
- Subject has Body Mass Index (BMI) < 18 kg/m2 or > 35 kg/m2.
- Subject is a female who is pregnant, breast-feeding, or planning to be pregnant in next 12 months.
- Subject has clinically significant abnormal screening laboratory test results per the Institution specific reference laboratory normal values for the following:
- White blood cells (total)
- Hematocrit
- Platelets
- Prothrombin time or INR
- Partial thromboplastin time
- Positive β-HCG Pregnancy test (if female)
- Subject has evidence of severe disease which in the judgment of the Investigator may compromise survival for the duration of the study (at least 12 months) e.g.:
- HIV/AIDs
- Active malignancy
- Stroke or Transient Ischemic attack (TIA) within 12 months of Screening visit
- Myocardial infarction within six (6) months of the Screening visit
- Congestive heart failure within six (6) months of the Screening visit defined as clinical evidence of right or left heart failure or left ventricular ejection fraction < 45% on echocardiogram
- Subject has uncontrolled diabetes mellitus.
- Subject has any other condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject including but not limited to alcoholism, high risk for drug abuse, or noncompliance in returning for follow-up visits.
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
United Kingdom4 sites
University Hospital of Wales
Cardiff, CF14 4XW
Golden Jublilee National Hospital
Clydebank, Scotland, G81 4DY
Royal Brompton Hospital
London, SW3 6NP
Nottingham University Hospitals
Nottingham, NG5 1PB
Germany3 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Ruhrlandklinik Essen
Essen, 45239
ThoraxKlinik
Heidelberg, 69126
Australia2 sites
The Wesley Hospital
Brisbane
Macquarie University Hospital
Sydney
Switzerland1 site
University Hospital of Zurich
Zurich, Rämistrasse 100, 8006
About this study
Official title: Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema; A Multicenter, Prospective Trial
This is a prospective, open-label, multi-center, single-arm study to be conducted at up to 20 investigational sites. The Study plans to enroll up to 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System to occlude collateral air channels in a target lung lobe with collateral ventilation (CV) and convert the target lung lobe to having little to no collateral ventilation. Subjects can then receive Zephyr Valves to achieve atelectasis in the targeted lobe, once AeriSeal has converted the CV+ lobe to a CV- one. Therefore, the study will have two Stages:
- Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System; conversion of the CV+ target lobe to CV-. Conversion of collateral ventilation will be evaluated by Chartis after 45 days. In the case of unsuccessful conversion, a second treatment of AeriSeal may be attempted, provided that the total application volume from both the initial and the repeat treatments does not exceed 40 mL in up to three (3) segments.
Read more
Clinical Assessments post-AeriSeal will be conducted at 28 and 45 days after first treatment and repeated after the second treatment, if applicable. For the purpose of protocol follow-up, the Day 45 post-AeriSeal final treatment will equal Day 0 for Stage 2.
- Stage 2 will include successfully converted subjects; CV+ to CV- conversion in Stage 1. Converted CV- target lobes will follow standard of care and receive CE marked Zephyr Endobronchial valves per the Zephyr IFU to perform bronchoscopic lung volume reduction (BLVR).
Clinical assessments will be conducted at 45 Days, 3-months, 6-months, and 12-months post-Zephyr Valve procedure.
Read the detailed description
Severe emphysema subjects will be consented using an Ethics Committee approved Informed Consent Form (ICF) for baseline evaluations. Subjects with ≥ 50% lobar emphysema destruction (evaluated quantitatively by using percentage lung volume occupied by low-attenuation regions/voxels) and identified as potentially having collateral ventilation, with fissure completeness ≥ 80% from the Quantitative Computed Tomography (QCT) report (CV status later to be confirmed by Chartis assessment at Visit 2) will undergo additional QCT assessment for the feasibility of directing AeriSeal to the appropriate segment to seal the anatomical defect. Subjects in whom this is considered feasible will be enrolled.
Enrolled subjects will undergo a bronchoscopy procedure during which the presence of collateral ventilation will be confirmed using the Chartis Pulmonary Assessment System (Pulmonx Corporation) and if confirmed, will undergo AeriSeal treatment in the segment(s) feeding the collateral channel. A minimum 10 mL volume of AeriSeal will be delivered per segment, with a total delivered volume limit of 40 mL per subject (including re-treatment, if needed) in a total of three segments. Subjects will be hospitalized for a minimum of two (2) nights for observation and discharged if stable. Following discharge, subjects will be contacted daily for at least 7 days via telephone to assess status and solicit any Adverse Events.
Subjects that have little to no collateral ventilation at the initial bronchoscopy, as assessed by the Chartis Pulmonary Assessment System, will be exited from the study.
Six (6) weeks following the AeriSeal treatment, subjects will undergo a second bronchoscopy procedure for assessment of collateral ventilation status of the AeriSeal treated lobe with Chartis. If the Chartis assessment shows presence of collateral ventilation (CV+) at the lobar level, Chartis will be used to assess collateral ventilation at the segmental level to identify the segment with open collaterals. A second treatment with AeriSeal will be considered, provided the total delivered volume inclusive of the original treatment does not exceed 40 mL per subject. The post-procedure follow-up assessments for the second treatment will be repeated as after the initial treatment.
If the Chartis assessment determines little to no collateral ventilation (CV-) in the AeriSeal treated lobe, the lobe will be treated with Zephyr Valves as per the standard valve placement procedure. Subject will be hospitalized for a minimum of three (3) nights post-valve placement procedure and discharged with follow-up in accordance with this protocol, which includes standard post-valve placement follow-up.
Subjects who do not convert from CV+ to CV- status will continue to be observed for safety through 12 months following AeriSeal treatment or re-treatment, whichever is later.
The primary AeriSeal endpoint is the percentage of study subjects that are successfully converted from a positive collateral ventilation (CV+) status in the treated lobe to having little to no collateral ventilation (CV-) in the treated lobe.
Following the procedure for Zephyr Valve placement, subjects will be required to undergo Pulmonary Rehabilitation as per the local/national guidelines of each participating institution; at least 20 supervised sessions. A High Resolution Computed Tomography (HRCT) will be performed at 45-days post-Zephyr Valve procedure to determine Treated Lobe Volume Reduction (TLVR). Lung function will be assessed by measuring post-bronchodilator FEV1. A valve adjustment procedure will be considered if there is lack of TLVR (≤ 350 mL reduction from the pre-valve assessment) following evaluation of the High-resolution computed tomography (HRCT) to determine which valve needs to be replaced or addition of a new valve at a previously missed airway. Subjects will also be evaluated at 3-months, 6-months, and 12 months following Zephyr Valve placement.
- Conditions
- Emphysema, COPD, Severe Emphysema
- Being tested
- AeriSeal, Zephyr Valves
- Keywords
- Bronchoscopic lung volume reduction, Zephyr Valves, AeriSeal
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AeriSealDevice
The AeriSeal Foam functions by blocking both small airways and collateral channels causing absorption atelectasis in the treated region of the lung. Occlusion with the foam also yields a targeted fibrotic response which durably reduces lung hyperinflation. The reduction in hyperinflation allows the healthier parts of the lung to re-inflate and improve breathing mechanics and gas exchange. In this study, the AeriSeal delivery will be limited to three segments that contain the collateral channel(s) between lung lobes. A minimum 10 mL volume of AeriSeal will be delivered per segment, with a total delivered volume limit of 40 mL per subject (including re-treatment, if needed) in a total of three segments.
Zephyr ValvesDevice
Also called Bronchoscopic Lung Volume Reduction (BLVR), Zephyr System
The Zephyr Valves are implantable bronchial valves intended to control airflow in order to improve lung function in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks.
| Study group | Role | What they receive |
|---|---|---|
| AeriSeal and Zephyr Valve Treatment | Other | Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System (conversion of the CV+ target lobe to CV-).
Stage 2 will include successfully converted subjects in Stage 1. Converted CV- target lobes will follow standard of care and receive the Zephyr Endobronchial valves per the Zephyr Instructions for Use (IFU) to perform bronchoscopic lung volume reduction (BLVR). Receives: Device: AeriSeal; Device: Zephyr Valves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects converted from a positive collateral ventilation status (CV+) to having little to no collateral ventilation (CV-) in the treated lobe.
The primary AeriSeal endpoint will be the percentage of study subjects that are successfully converted from a positive collateral ventilation status (CV+) in the treated lobe to having little to no collateral ventilation (CV-) in the treated lobe six (6) weeks after delivery of AeriSeal.
Measured: 6-weeks post-AeriSeal treatment
Treated Lobe Volume Reduction (TLVR) responders
The primary Zephyr Valve endpoint is the percentage of subjects achieving TLVR ≥ 350 mL (TLVR Responders) at 45-days post-valve treatment. That is, the percentage of CV+ to CV- converted subjects from Stage 1 who subsequently receive valves and have Treated Lobe Volume Reduction (TLVR) of ≥ 350 mL, via High-resolution computed tomography (HRCT) at 45-days post-valve treatment.
Measured: 45-days post-Zephyr Valve treatment
Secondary outcomes (2)
Forced Expiratory Volume in 1 second (FEV1)
Post-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) change from Baseline to 3-months (Absolute and Percent changes)
Measured: 3-months
Residual volume (RV)
Residual volume (RV) change from Baseline to 3-months (Absolute and Percent changes).
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start15 Dec 2020
- Primary completion24 Oct 2023
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System (conversion of the CV+ target lobe to CV-). Stage 2 will include successfully converted subjects in Stage 1. Converted CV- target lobes will follow standard of care and receive the Zephyr Endobronchial valves per the Zephyr Instructions for Use (IFU) to perform bronchoscopic lung volume reduction (BLVR).
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmonx Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joshua Percy, Study director, Pulmonx Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559464
- Sponsor's protocol ID
- 630-0030-01
- Acronym
- CONVERT
- Status last verified
- Oct 2024
- First submitted
- 16 Sep 2020
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema; A Multicenter, Prospective Trial
- ClinicalTrials.gov ID
- NCT04559464
- Acronym / sponsor ID
- CONVERT / 630-0030-01
- Conditions
- Emphysema, COPD, Severe Emphysema
- Keywords
- Bronchoscopic lung volume reduction, Zephyr Valves, AeriSeal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Pulmonx CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 22 Sep 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.
This is a prospective, open-label, multi-center, single-arm study to be conducted at up to 20 investigational sites. The Study plans to enroll up to 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System to occlude collateral air channels in a target lung lobe with collateral ventilation (CV) and convert the target lung lobe to having little to no collateral ventilation. Subjects can then receive Zephyr Valves to achieve atelectasis in the targeted lobe, once AeriSeal has converted the CV+ lobe to a CV- one. Therefore, the study will have two Stages:
- Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System; conversion of the CV+ target lobe to CV-. Conversion of collateral ventilation will be evaluated by Chartis after 45 days. In the case of unsuccessful conversion, a second treatment of AeriSeal may be attempted, provided that the total application volume from both the initial and the repeat treatments does not exceed 40 mL in up to three (3) segments.
Clinical Assessments post-AeriSeal will be conducted at 28 and 45 days after first treatment and repeated after the second treatment, if applicable. For the purpose of protocol follow-up, the Day 45 post-AeriSeal final treatment will equal Day 0 for Stage 2.
- Stage 2 will include successfully converted subjects; CV+ to CV- conversion in Stage 1. Converted CV- target lobes will follow standard of care and receive CE marked Zephyr Endobronchial valves per the Zephyr IFU to perform bronchoscopic lung volume reduction (BLVR).
Clinical assessments will be conducted at 45 Days, 3-months, 6-months, and 12-months post-Zephyr Valve procedure.
Detailed description
Severe emphysema subjects will be consented using an Ethics Committee approved Informed Consent Form (ICF) for baseline evaluations. Subjects with ≥ 50% lobar emphysema destruction (evaluated quantitatively by using percentage lung volume occupied by low-attenuation regions/voxels) and identified as potentially having collateral ventilation, with fissure completeness ≥ 80% from the Quantitative Computed Tomography (QCT) report (CV status later to be confirmed by Chartis assessment at Visit 2) will undergo additional QCT assessment for the feasibility of directing AeriSeal to the appropriate segment to seal the anatomical defect. Subjects in whom this is considered feasible will be enrolled.
Enrolled subjects will undergo a bronchoscopy procedure during which the presence of collateral ventilation will be confirmed using the Chartis Pulmonary Assessment System (Pulmonx Corporation) and if confirmed, will undergo AeriSeal treatment in the segment(s) feeding the collateral channel. A minimum 10 mL volume of AeriSeal will be delivered per segment, with a total delivered volume limit of 40 mL per subject (including re-treatment, if needed) in a total of three segments. Subjects will be hospitalized for a minimum of two (2) nights for observation and discharged if stable. Following discharge, subjects will be contacted daily for at least 7 days via telephone to assess status and solicit any Adverse Events.
Subjects that have little to no collateral ventilation at the initial bronchoscopy, as assessed by the Chartis Pulmonary Assessment System, will be exited from the study.
Six (6) weeks following the AeriSeal treatment, subjects will undergo a second bronchoscopy procedure for assessment of collateral ventilation status of the AeriSeal treated lobe with Chartis. If the Chartis assessment shows presence of collateral ventilation (CV+) at the lobar level, Chartis will be used to assess collateral ventilation at the segmental level to identify the segment with open collaterals. A second treatment with AeriSeal will be considered, provided the total delivered volume inclusive of the original treatment does not exceed 40 mL per subject. The post-procedure follow-up assessments for the second treatment will be repeated as after the initial treatment.
If the Chartis assessment determines little to no collateral ventilation (CV-) in the AeriSeal treated lobe, the lobe will be treated with Zephyr Valves as per the standard valve placement procedure. Subject will be hospitalized for a minimum of three (3) nights post-valve placement procedure and discharged with follow-up in accordance with this protocol, which includes standard post-valve placement follow-up.
Subjects who do not convert from CV+ to CV- status will continue to be observed for safety through 12 months following AeriSeal treatment or re-treatment, whichever is later.
The primary AeriSeal endpoint is the percentage of study subjects that are successfully converted from a positive collateral ventilation (CV+) status in the treated lobe to having little to no collateral ventilation (CV-) in the treated lobe.
Following the procedure for Zephyr Valve placement, subjects will be required to undergo Pulmonary Rehabilitation as per the local/national guidelines of each participating institution; at least 20 supervised sessions. A High Resolution Computed Tomography (HRCT) will be performed at 45-days post-Zephyr Valve procedure to determine Treated Lobe Volume Reduction (TLVR). Lung function will be assessed by measuring post-bronchodilator FEV1. A valve adjustment procedure will be considered if there is lack of TLVR (≤ 350 mL reduction from the pre-valve assessment) following evaluation of the High-resolution computed tomography (HRCT) to determine which valve needs to be replaced or addition of a new valve at a previously missed airway. Subjects will also be evaluated at 3-months, 6-months, and 12 months following Zephyr Valve placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System (conversion of the CV+ target lobe to CV-). Stage 2 will include successfully converted subjects in Stage 1. Converted CV- target lobes will follow standard of care and receive the Zephyr Endobronchial valves per the Zephyr Instructions for Use (IFU) to perform bronchoscopic lung volume reduction (BLVR).
| Arm | Type | Receives |
|---|---|---|
| AeriSeal and Zephyr Valve Treatment | Other | Device: AeriSeal, Device: Zephyr ValvesStage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System (conversion of the CV+ target lobe to CV-). Stage 2 will include successfully converted subjects in Stage 1. Converted CV- target lobes will follow standard of care and receive the Zephyr Endobronchial valves per the Zephyr Instructions for Use (IFU) to perform bronchoscopic lung volume reduction (BLVR). |
Who may qualify
- Ages
- 40 to 75 years
- 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 and ≤ 75 years of age at the time Informed Consent signature.
- Subject has at least one lobe with ≥ 50% emphysema destruction (at -910 HU) as determined by QCT.
- Subject has a diagnosis of homogenous or heterogeneous emphysema, confirmed by HRCT scan. Heterogeneous emphysema defined as ≥ 15% difference (at -910 HU) in emphysema destruction score of adjacent lobes by HRCT.
- Subject has a gap in the interlobar fissure that corresponds to one or more segments as determined by QCT.
Key exclusion criteria (50 listed)
- Subject has severe bullous emphysema where bulla is ≥ 1/3 of the total lung volume.
- Subject has had prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior ipsilateral pleurodesis, or prior endobronchial lung volume reduction therapy of any type.
- Subject has evidence of active respiratory infection.
- Subject has an ongoing COPD exacerbation or bronchospasm.
- Subject has a known allergy to the device components:
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 |
|---|---|---|
| AeriSealThe AeriSeal Foam functions by blocking both small airways and collateral channels causing absorption atelectasis in the treated region of the lung. Occlusion with the foam also yields a targeted fibrotic response which durably reduces lung hyperinflation. The reduction in hyperinflation allows the healthier parts of the lung to re-inflate and improve breathing mechanics and gas exchange. In this study, the AeriSeal delivery will be limited to three segments that contain the collateral channel(s) between lung lobes. A minimum 10 mL volume of AeriSeal will be delivered per segment, with a total delivered volume limit of 40 mL per subject (including re-treatment, if needed) in a total of three segments. | Device | AeriSeal and Zephyr Valve Treatment |
| Zephyr ValvesAlso: Bronchoscopic Lung Volume Reduction (BLVR), Zephyr SystemThe Zephyr Valves are implantable bronchial valves intended to control airflow in order to improve lung function in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks. | Device | AeriSeal and Zephyr Valve Treatment |
Primary outcome
Percentage of subjects converted from a positive collateral ventilation status (CV+) to having little to no collateral ventilation (CV-) in the treated lobe.
Time frame: 6-weeks post-AeriSeal treatment
The primary AeriSeal endpoint will be the percentage of study subjects that are successfully converted from a positive collateral ventilation status (CV+) in the treated lobe to having little to no collateral ventilation (CV-) in the treated lobe six (6) weeks after delivery of AeriSeal.
Treated Lobe Volume Reduction (TLVR) responders
Time frame: 45-days post-Zephyr Valve treatment
The primary Zephyr Valve endpoint is the percentage of subjects achieving TLVR ≥ 350 mL (TLVR Responders) at 45-days post-valve treatment. That is, the percentage of CV+ to CV- converted subjects from Stage 1 who subsequently receive valves and have Treated Lobe Volume Reduction (TLVR) of ≥ 350 mL, via High-resolution computed tomography (HRCT) at 45-days post-valve treatment.
2 secondary outcomes
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 3-months
Residual volume (RV)
Time frame: 3-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 4 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Emphysema
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingEarly Phase 1
Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema
Air Trapping, Emphysema
RecruitingPhase 3
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
RecruitingPhase 1
A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
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.
Joshua Percy study director
Pulmonx Corporation
14 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AeriSeal and Zephyr Valves in people with Emphysema and COPD, run by Pulmonx Corporation at 14 sites in 7 countries.
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 50 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom, Germany, Australia, France, Italy and 2 more countries. 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?
Percentage of subjects converted from a positive collateral ventilation status (CV+) to having little to no collateral ventilation (CV-) in the treated lobe. (time frame: 6-weeks post-AeriSeal treatment). The study lists 2 primary outcomes in all. 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 4 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.