Emphysema, PulmonaryCONVERT_IINCT06035120
An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema
A study testing AeriSeal System in people with Emphysema, Pulmonary and Emphysema or COPD, run by Pulmonx Corporation at 38 sites in 10 countries.
Trial summary
This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Emphysema, Pulmonary, Emphysema or COPD
- What is being tested?
- AeriSeal System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 38 sitesin 10 countries
- Study dates
- 22 Feb 2024to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 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 aged ≥ 40 and ≤ 80 years at the time of the ICF signature date.
- Subject has completed a documented pulmonary rehabilitation (in clinic or home-based) program within 12 months prior to Baseline.
- Subject has stopped smoking for at least 8 weeks prior to the ICF signature date as confirmed by carboxyhemoglobin or cotinine levels.
- Subject has a recent HRCT meeting the scan parameter requirements and performed within 3 months of the ICF signature date with the following findings at -910 Hounsfield Units:
- At least one (1) lobe with segmental emphysema destruction score ≥ 50%.
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- Subject has heterogenous emphysema, defined as difference in emphysema destruction score of ≥ 15 between the density scores of the target lobe and the ipsilateral non-target lobe(s) per QCT report with % voxel density of < -910 HU. For non-target lobes that include the RML, calculate the combination of non-target lobes as a single density score using volume-weighted percent.
- LUL, LLL, RUL, RLL, or RUL+RML are targets for valve intervention.
- Subject has a gap in the interlobar fissure that corresponds to one or more segments and the fissure(s) contacting the target lobe is ≥ 80% complete per QCT report.
- Subject has 98% of the fissure gap confined to a maximum of 3 segments within the target lobe per Fissure Targeting Report (FTR).
- Subject has 6MWD ≥ 150 m and ≤ 450 m.
- Subject has clinically significant dyspnea with an mMRC score of ≥ 2.
- Subject has post-bronchodilation FEV1 ≥ 15% predicted and ≤ 45% predicted.
- Subject has an FEV1/FVC ratio of < 0.7.
- Subject has post-bronchodilation TLC, measured by body plethysmography, ≥ 100% predicted.
- Subject has post-bronchodilation RV ≥ 175% predicted, measured by body plethysmography.
- Subject has post-bronchodilation DLCO ≥ 20% predicted.
- Subject has received preventative vaccinations against potential respiratory infections, including COVID-19, consistent with local recommendation or policy.
- Subject is on optimal medical management for more than one month prior to the ICF signature date.
- Subject has collateral ventilation (CV+) as confirmed per the Chartis assessment prior to the AeriSeal Index Procedure.
Who cannot join
- Subject has prior lung volume reduction surgery, lobectomy or pneumonectomy, lung transplantation, airway stent placement, pleurodesis, or BLVR of any type, except BLVR using Zephyr Valve with < 50% TLVR at 6 months, followed by valve removal > 6 months prior to ICF signature date.
- Subject has visible radiological abnormality on HRCT scan such as pulmonary nodule greater than 0.8 cm in diameter (does not apply, if present for 2 years or more without increase in size or if deemed benign by biopsy) or active pulmonary infection (e.g., unexplained parenchymal infiltrate, significant interstitial lung disease or significant pleural disease).
- Post-COVID-19 pathology on CT, including ground glass opacities with or without consolidation, adjacent pleura thickening, interlobular septal thickening, or air bronchograms.
- Large bullae encompassing greater than 1/3 of the total lung.
- Subject had 3 or more COPD exacerbations requiring hospitalization within 12 months preceding the ICF signature date or a COPD exacerbation requiring hospitalization within 8 weeks of the ICF signature date. Subjects may be re-considered for future enrollment.
- Subject has asthma as their primary diagnosis.
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- Subject has chronic bronchitis (defined as greater than 4 tablespoons of sputum production per day) as their primary diagnosis.
- Subject has clinically significant bronchiectasis.
- Subjects with evidence of active respiratory infection should be considered for enrollment only after satisfactory resolution.
- Subject requires invasive ventilatory support. Note: The use of Continuous Positive Airway Pressure (CPAP) or BiPAP devices for sleep apnea is permitted.
- Subject has severe gas exchange abnormalities as defined by any one of the following tests, conducted at rest, on room air, as tolerated.
- PaCO2 ≥ 50 mm Hg (6.7 kPa)
- PaO2 < 45 mm Hg (6.0 kPa)
- Subject has pulmonary hypertension, defined as mean pulmonary systolic pressure > 45 mm Hg.
- Subject has known documented alpha-1 antitrypsin deficiency.
- Subject has clinically significant hematological disorder.
- Subject has recent significant unplanned or unexplained weight loss or other relevant comorbidities considered by the investigator to be potentially confounding or limiting to the subject's participation in the study.
- Subject has non-atrial arrhythmias or conduction abnormalities on EKG.
- Subject has high cardiac risk after undergoing cardiac risk assessment in accordance with published guidelines (Fleisher 2007) or has ischemic heart disease, congestive heart failure, cerebrovascular disease (stroke or TIA within 6 months of the ICF signature date), serum creatinine > 2.0 mg/dL (177 μmol/L), or left ventricular ejection fraction (LVEF) < 45% on echocardiogram.
- Subject has uncontrolled exercise induced syncope.
- Subject has evidence of severe disease which in the judgment of the investigator may compromise the anticipated treatment effect or the subject's survival for the duration of at least 12 months.
- 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.
- Subject cannot tolerate corticosteroids or relevant antibiotics.
- Subject use of systemic corticosteroids > 20 mg/day prednisolone or equivalent within four (4) weeks of the ICF signature date. Subjects may be re-considered for future enrollment.
- Subject use of immunosuppressive agents within four (4) weeks of the ICF signature date. Subjects may be re-considered for future enrollment.
- Subject is unable to temporarily discontinue heparins and oral anticoagulants (e.g., warfarin, dicumarol) according to local pre-procedural protocols. Note: Antiplatelet drugs including aspirin, thienopyridines and ticagrelor are permitted.
- Subject has allergy or sensitivity to medications required to safely perform bronchoscopy under conscious sedation or general anesthesia.
- Subject has known allergy to the following device components: Polyether block amide (PEBAX), Polyvinyl Alcohol or Glutaraldehyde, Nitinol (nickel-titanium) or its constituent metals (nickel or titanium) or Silicone.
- Subject is a female who is pregnant (positive βHCG Pregnancy test), breast-feeding, or planning to be pregnant in the next 12 months.
- Subject has Body Mass Index < 18 kg/m2 or > 35 kg/m2.
- Subject participated in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the ICF signature date. Note: 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.
Trial locations and contacts
38 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
Marie Barrigar contact
38 sites in 10 countries
United States20 sites, 18 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Maria Lopez Giron, 786-967-8448, mlopezgi@bidmc.harvard.edu
Adnan Majid, MD, amajid@bidmc.harvard.edu
- Withdrawn
Brigham Lung Center
Boston, Massachusetts, 02115
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Adriana Martinez, 312-926-6680, adriana.martinez@northwestern.edu
Momen Wahidi, MD, momen.wahidi@nm.org
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Jessica Tuck, 773-795-4434, Jessica.Tuck@bsd.uchicago.edu
Ajay Wagh, MD, awagh@bsd.uchicago.edu
- Withdrawn
Cleveland VA Northeast
Cleveland, Ohio, 44106
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75235
Khyati Vadera, 214-645-8464, khyati.vadera@utsouthwestern.edu
Muhanned Abu-Hijleh, MD, muhanned.abu-hijleh@utsouthwestern.edu
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Ruth George, 313-916-1791, rgeorg11@hfhs.org
Avi Cohen, acohen4@hfhs.org
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Alma Khan, 703-776-5912, alma.khan2@inova.org
Priya Patel, MD, priya.patel2@inova.org
- Recruiting
Saint Francis Hospital and Medical Center (Trinity Health of New England)
Hartford, Connecticut, 06105
Kendra Williams, 860-714-7161, KLWillia@TrinityHealthOfNE.org
Amber Newman, 860-714-4055, Amber.Newman@TrinityHealthOfNE.org
- Recruiting
Fort Sanders Regional Medical Center (StatCare)
Knoxville, Tennessee, 37916
Jennifer Thornton, 865-588-8831, jthornton@statcaremed.net
Varun Shah, MD, vshah@statcaremed.net
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Srushan Shankara Bhaktula, 859-562-0882, srushan.bhaktula@uky.edu
Ashish Maskey, MD, ashish.maskey@uky.edu
- Recruiting
UCHealth - Medical Center of the Rockies
Loveland, Colorado, 80538
Abby Dowling, 970-624-1580, Abby.Dowling@uchealth.org
Kirk DePriest, MD, Kirk.DePriest@uchealth.org
- Recruiting
Medical College of Wisconsin (MCW)
Milwaukee, Wisconsin, 53226
Alexandra Cook, 414-955-6839, alcook@mcw.edu
Jonathan Kurman, MD, jkurman@mcw.edu
- Recruiting
Orlando Health
Orlando, Florida, 32806
Donya Shahnavaz, 321-841-7303, donya.shahnavaz@orlandohealth.com
Mark Vollenweider, MD, Mark.Vollenweider@orlandohealth.com
- Recruiting
OSF Saint Francis Medical Center
Peoria, Illinois, 61606
Kimberly Hartwig, 309-655-4229, kimberly.hartwig@osfhealthcare.org
Patrick Whitten, MD, patrick.e.whitten@osfhealthcare.org
- Recruiting
Penn Medicine
Philadelphia, Pennsylvania, 19107
Katelyn Lobo, 215-615-0132, katelyn.lobo@pennmedicine.upenn.edu
Kevin Ma, MD, kevin.ma@pennmedicine.upenn.edu
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Helga Criner, 215-707-1559, Lii-Yoong.Criner@tuhs.temple.edu
Gerard Criner, gerard.criner@tuhs.temple.edu
- Recruiting
Banner University Medical Center
Phoenix, Arizona, 85006
Maria Masters, 602-827-2363, mlmasters@arizona.edu
Raed Alalawi, MD, raed.alalawi@bannerhealth.edu
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Paige Rutter, 412-295-7659, paige.rutter@ahn.org
Stephanie Baltaji, MD, Stephanie.Baltaji@ahn.org
- Recruiting
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213
Paula Consolaro, 412-605-1904, consolaropj@upmc.edu
Frank Sciurba, MD, sciurbafc@upmc.edu
Germany5 sites, 5 recruiting
- Recruiting
Ruhrlandklink, Uni Essen
Essen, Germany
Jennifer Thaelker, +49 02 01 433 4830, jennifer.thaelker@rlk.uk-essen.de
Ruediger Karpf-Wissel, MD, ruediger.karpf-wissel@rlk.uk-essen.de
- Recruiting
Universitätsklinikum Halle
Halle, Germany
Maria Reuss, +49 345 557 352, maria.reuss@uk-halle.de
Stephan Eisenmann, MD, stephan.eisenmann@uk-halle.de
- Recruiting
Asklepios Klinik Barmbek
Hamburg, Germany
Magdalena Karimi, +49 40 18 1882 6317, m.karimi@asklepios.com
Ralf Eberhardt, MD, r.eberhardt@asklepios.com
- Recruiting
Thoraxklinik am Universitats klinikum Heidelberg
Heidelberg, Germany
Sevilay Oeztuerk, +49 6221 396 1211, sevilay.oeztuerk@med.uni-heidelberg.de
Felix Herth, MD, Felix.Herth@med.uni-heidelberg.de
- Recruiting
Lungenklinik Hemer
Hemer, Germany
Birte Schwarz, +49 02 372 908 2179, birte.schwarz@lkhemer.de
Kaid Darwiche, MD, Kaid.Darwiche@lkhemer.de
France4 sites, 4 recruiting
- Recruiting
CHU Limoges
Limoges, France
Eloise Dobbels, +33 05 55 05 67 45, Eloise.Dobbels@chu-limoges.fr
Thomas Egenod, MD, thomas.egenod@chu-limoges.fr
- Recruiting
Hopital Bichat-APHP
Paris, France
Hakima Rabia, +33 01 40 25 69 16, hakima.rabia@aphp.fr
Armelle Marceau, MD, armelle.marceau@aphp.fr
- Recruiting
CHRU Strasbourg
Strasbourg, France
Julien Stauder, +33 03 69 55 03 45, julien.stauder@chru-strasbourg.fr
Michele Porzio, MD, michele.porzio@chru-strasbourg.fr
- Recruiting
CHU Toulouse
Toulouse, France
Emma Devienne, +33 05 67 77 18 59, devienne.e@chu-toulouse.fr
Nicolas Guibert, MD, guibert.n@chu-toulouse.fr
Australia3 sites, 3 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, Australia
Jenny McGrath, +61 08 7074 5244, Health.CRPL@sa.gov.au
Phan Nguyen, MD, phantien.nguyen@sa.gov.au
- Recruiting
Wesley Hospital
Brisbane, Australia
Chris Henderson, +61 07 3721 1724, chris.henderson@wesleyresearch.org.au
Farzad Bashirzadeh, MD, farzad.bashirzadeh@health.qld.gov.au
- Recruiting
Macquarie University
Macquarie Park, Australia
Jessica Lewis, +61 9812 2974, jessica.lewis@mq.edu.au
Alvin Ing, MD, alvin.ing@mq.edu.au
Austria1 site, 1 recruiting
- Recruiting
Klinik Floridsdorf
Vienna, Austria
Raphaela Wahrmann, +43 664 4385355, raphaela.wahrmann@extern.gesundheitsverbund.at
Arschang Valipour, MD, arschang.valipour@gesundheitsverbund.at
Italy1 site, 1 recruiting
- Recruiting
ASST Spedali Civili, University Hospital
Brescia, Italy
Guido Levi, MD, +39 030 399 5593, guido.levi@asst-spedalicivili.it
Michela Bezzi, MD, michela.bezzi@asst-spedalicivili.it
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, Netherlands
Karin Klooster, PhD, +31 50 361 3279, k.klooster@umcg.nl
Dirk-Jan Slebos, MD, d.j.slebos@umcg.nl
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario y Politecnico La Fe
Valencia, Spain
Elsie Daviana Del Valle Meneses Petersen, MD, elsie_daviana@iislafe.es
Enrique Cases Viedma, MD, cases_enr@gva.es
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton Hospital
London, England
Ashish Karir, MD, +44 0207 351 8030, a.karir@rbht.nhs.uk
Pallav Shah, MD, p.shah@rbht.nhs.uk
About this study
Official title: An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema: The CONVERT II Trial
This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV- status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic lung volume reduction (BLVR) and be followed for 24 months.
Read the detailed description
This is a multicenter, prospective, single-arm, pivotal trial with a 24-month follow-up to evaluate the safety and effectiveness of the AeriSeal System to block CV. The study plans to enroll up to 200 subjects at up to 35 clinical centers in US and OUS. Study subjects will be patients with severe, heterogeneous emphysema and collateral ventilation in the lobe targeted who are candidates for BLVR. Subjects meeting initial eligibility will undergo a bronchoscopy procedure under general anesthesia during which the presence of CV will be confirmed using Chartis. All enrolled subjects meeting final eligibility will undergo the AeriSeal procedure. Conversion of collateral ventilation status from CV+ to CV- in the target lobe will be evaluated by Chartis at Day 45 post-AeriSeal treatment (primary effectiveness endpoint). All subjects not converted from CV+ to CV- status will undergo a repeat of the AeriSeal procedure, provided that the total volume from both the initial and the repeat treatments does not exceed 40 mL in up to 3 segments. All subjects converted from CV+ to CV- status after either the index or repeat AeriSeal procedure will undergo BLVR with Zephyr Valve per standard of care in accordance with the approved instructions for use and will be followed through Month 24 (end of study). All CV+ subjects who remain CV+ after the repeat procedure or do not undergo the repeat AeriSeal procedure will be followed through Month 24 (end of study).
- Conditions
- Emphysema, Pulmonary, Emphysema or COPD
- Being tested
- AeriSeal System
- Keywords
- Collateral Ventilation, Bronchoscopic Lung Volume Reduction, Hyperinflation
- Medical subject headings
- Pulmonary Emphysema, Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AeriSeal SystemDevice
The AeriSeal System comprises AeriSeal Foam and the AeriSeal Balloon Catheter Preparation Kit that is used for bronchoscopic delivery of AeriSeal Foam to the targeted regions of the lung.
| Study group | Role | What they receive |
|---|---|---|
| AeriSeal | Experimental | All enrolled subjects meeting final eligibility will undergo the AeriSeal procedure to block collateral ventilation by closing the lobar fissure gaps or collateral air channels. Receives: Device: AeriSeal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Converters, responder rate
The percentage of study subjects that successfully convert from a positive collateral ventilation status (CV+) in the treated lobe to having little to no collateral ventilation (CV-) by Chartis.
Measured: 45 days post-AeriSeal treatment (index or repeat)
Secondary outcomes (4)
Post-bronchodilator forced expiratory volume in 1 second (FEV1), responder rate
The percentage of converters achieving a ≥ 12% increase in FEV1
Measured: Month 6 post-Zephyr Valve
Residual volume (RV), responder rate
The percentage of converters achieving a ≥ 310 mL decrease in RV
Measured: Month 6 post-Zephyr Valve
Treated lobe volume reduction (TLVR) by high-resolution computed tomography (HRCT), responder rate
The percentage of converters achieving a ≥ 350 mL decrease in TLVR
Measured: Month 6 post-Zephyr Valve
St. George's Respiratory Questionnaire (SGRQ), responder rate
The percentage of converters achieving a ≥ 4-point decrease in SGRQ total score
Measured: Month 6 post-Zephyr Valve
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start22 Feb 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emphysema, PulmonaryStudies 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
- The study is designed as a single-arm clinical trial in which eligible subjects with an identified fissure gap in the target lobe will be treated with the AeriSeal System to determine the rate of conversion from having collateral ventilation (CV+) to having little to no collateral ventilation (CV-). Subjects who convert to CV- status with AeriSeal will then undergo BLVR using Zephyr Valve per standard of care.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmonx Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Narinder Shargill, PhD, Study director, Pulmonx Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035120
- Sponsor's protocol ID
- 630-2000-01
- Acronym
- CONVERT_II
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All data will be aggregated and analyzed. No IPD be made available for sharing to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema: The CONVERT II Trial
- ClinicalTrials.gov ID
- NCT06035120
- Acronym / sponsor ID
- CONVERT_II / 630-2000-01
- Conditions
- Emphysema, Pulmonary, Emphysema or COPD
- Keywords
- Collateral Ventilation, Bronchoscopic Lung Volume Reduction, Hyperinflation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pulmonx CorporationIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 13 Sep 2023 (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 planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV- status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic lung volume reduction (BLVR) and be followed for 24 months.
Detailed description
This is a multicenter, prospective, single-arm, pivotal trial with a 24-month follow-up to evaluate the safety and effectiveness of the AeriSeal System to block CV. The study plans to enroll up to 200 subjects at up to 35 clinical centers in US and OUS. Study subjects will be patients with severe, heterogeneous emphysema and collateral ventilation in the lobe targeted who are candidates for BLVR. Subjects meeting initial eligibility will undergo a bronchoscopy procedure under general anesthesia during which the presence of CV will be confirmed using Chartis. All enrolled subjects meeting final eligibility will undergo the AeriSeal procedure. Conversion of collateral ventilation status from CV+ to CV- in the target lobe will be evaluated by Chartis at Day 45 post-AeriSeal treatment (primary effectiveness endpoint). All subjects not converted from CV+ to CV- status will undergo a repeat of the AeriSeal procedure, provided that the total volume from both the initial and the repeat treatments does not exceed 40 mL in up to 3 segments. All subjects converted from CV+ to CV- status after either the index or repeat AeriSeal procedure will undergo BLVR with Zephyr Valve per standard of care in accordance with the approved instructions for use and will be followed through Month 24 (end of study). All CV+ subjects who remain CV+ after the repeat procedure or do not undergo the repeat AeriSeal procedure will be followed through Month 24 (end of study).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is designed as a single-arm clinical trial in which eligible subjects with an identified fissure gap in the target lobe will be treated with the AeriSeal System to determine the rate of conversion from having collateral ventilation (CV+) to having little to no collateral ventilation (CV-). Subjects who convert to CV- status with AeriSeal will then undergo BLVR using Zephyr Valve per standard of care.
| Arm | Type | Receives |
|---|---|---|
| AeriSeal | Experimental | Device: AeriSeal SystemAll enrolled subjects meeting final eligibility will undergo the AeriSeal procedure to block collateral ventilation by closing the lobar fissure gaps or collateral air channels. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subject is willing and able to provide informed consent and to participate in the study.
- Subject is aged ≥ 40 and ≤ 80 years at the time of the ICF signature date.
- Subject has completed a documented pulmonary rehabilitation (in clinic or home-based) program within 12 months prior to Baseline.
- Subject has stopped smoking for at least 8 weeks prior to the ICF signature date as confirmed by carboxyhemoglobin or cotinine levels.
- Subject has a recent HRCT meeting the scan parameter requirements and performed within 3 months of the ICF signature date with the following findings at -910 Hounsfield Units:
Key exclusion criteria (31 listed)
- Subject has prior lung volume reduction surgery, lobectomy or pneumonectomy, lung transplantation, airway stent placement, pleurodesis, or BLVR of any type, except BLVR using Zephyr Valve with < 50% TLVR at 6 months, followed by valve removal > 6 months prior to ICF signature date.
- Subject has visible radiological abnormality on HRCT scan such as pulmonary nodule greater than 0.8 cm in diameter (does not apply, if present for 2 years or more without increase in size or if deemed benign by biopsy) or active pulmonary infection (e.g., unexplained parenchymal infiltrate, significant interstitial lung disease or significant pleural disease).
- Post-COVID-19 pathology on CT, including ground glass opacities with or without consolidation, adjacent pleura thickening, interlobular septal thickening, or air bronchograms.
- Large bullae encompassing greater than 1/3 of the total lung.
- Subject had 3 or more COPD exacerbations requiring hospitalization within 12 months preceding the ICF signature date or a COPD exacerbation requiring hospitalization within 8 weeks of the ICF signature date. Subjects may be re-considered for future enrollment.
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 |
|---|---|---|
| AeriSeal SystemThe AeriSeal System comprises AeriSeal Foam and the AeriSeal Balloon Catheter Preparation Kit that is used for bronchoscopic delivery of AeriSeal Foam to the targeted regions of the lung. | Device | AeriSeal |
Primary outcome
Converters, responder rate
Time frame: 45 days post-AeriSeal treatment (index or repeat)
The percentage of study subjects that successfully convert from a positive collateral ventilation status (CV+) in the treated lobe to having little to no collateral ventilation (CV-) by Chartis.
4 secondary outcomes
Post-bronchodilator forced expiratory volume in 1 second (FEV1), responder rate
Time frame: Month 6 post-Zephyr Valve
Residual volume (RV), responder rate
Time frame: Month 6 post-Zephyr Valve
Treated lobe volume reduction (TLVR) by high-resolution computed tomography (HRCT), responder rate
Time frame: Month 6 post-Zephyr Valve
St. George's Respiratory Questionnaire (SGRQ), responder rate
Time frame: Month 6 post-Zephyr Valve
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. All data will be aggregated and analyzed. No IPD be made available for sharing to other researchers.
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A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingPhase 1/2
A Study of TSRA-196 in Adults With PiZZ Alpha-1 Antitrypsin Deficiency (AATD)
Alpha-1 Antitrypsin Deficiency (AATD)
RecruitingEarly Phase 1
Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema
Air Trapping, Emphysema
RecruitingPhase 4
Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
Alpha 1-Antitrypsin, COPD
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.
Marie Barrigar contact
Narinder Shargill, PhD study director
Pulmonx Corporation
38 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AeriSeal System in people with Emphysema, Pulmonary and Emphysema or COPD, run by Pulmonx Corporation at 38 sites in 10 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 20 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Germany, France, Australia, Austria and 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Kutzavitch, PhD (+1 650-216-0134, ckutzavitch@pulmonx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Converters, responder rate (time frame: 45 days post-AeriSeal treatment (index or repeat)). 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 17 Sep 2026.