RECRUITING

An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients with Severe Emphysema

Conditions

Emphysema, Pulmonary Emphysema or COPD Collateral Ventilation Bronchoscopic Lung Volume Reduction Hyperinflation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients with Severe Emphysema: the CONVERT II Trial

Quick Facts

Study Start:2024-02-22

Study Completion:2028-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06035120

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.

Ages Eligible for Study:22 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject is willing and able to provide informed consent and to participate in the study. 2. Subject is aged ≥ 22 and ≤ 80 years at the time of the ICF signature date. 3. Subject has completed a documented pulmonary rehabilitation (in clinic or home-based) program within 6 months prior to Baseline. 4. Subject has stopped smoking for at least 8 weeks prior to the ICF signature date as confirmed by carboxyhemoglobin or cotinine levels. 5. Subject has an HRCT from the screening institution within 3 months of the ICF signature date with the following findings at -910 Hounsfield Units: 1. At least one (1) lobe with segmental emphysema destruction score ≥ 50%. 2. 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. 3. LUL, LLL, RUL, RLL, or RUL+RML are targets for valve intervention. 4. 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. 5. Subject has 98% of the fissure gap confined to a maximum of 3 segments within the target lobe per Fissure Targeting Report (FTR). 6. Subject has 6MWD ≥ 250 m and ≤ 450 m. 7. Subject has clinically significant dyspnea with an mMRC score of ≥ 2. 8. Subject has post-bronchodilation FEV1 ≥ 15% predicted and ≤ 45% predicted. 9. Subject has an FEV1/FVC ratio of \< 0.7. 10. Subject has post-bronchodilation TLC, measured by body plethysmography, ≥ 100% predicted. 11. Subject has post-bronchodilation RV ≥ 175% predicted, measured by body plethysmography. 12. Subject has post-bronchodilation DLCO ≥ 20% predicted. 13. Subject has received preventative vaccinations against potential respiratory infections, including COVID-19, consistent with local recommendation or policy. 14. Subject is on optimal medical management for more than one month prior to the ICF signature date. 15. Subject has collateral ventilation (CV+) as confirmed per the Chartis assessment prior to the AeriSeal Index Procedure.	1. 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. 2. 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). 3. Post-COVID-19 pathology on CT, including ground glass opacities with or without consolidation, adjacent pleura thickening, interlobular septal thickening, or air bronchograms. 4. Large bullae encompassing greater than 1/3 of the total lung. 5. 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. 6. Subject has asthma as their primary diagnosis. 7. Subject has chronic bronchitis (defined as greater than 4 tablespoons of sputum production per day) as their primary diagnosis. 8. Subject has clinically significant bronchiectasis. 9. Subjects with evidence of active respiratory infection should be considered for enrollment only after satisfactory resolution. 10. Subject requires invasive ventilatory support. Note: The use of Continuous Positive Airway Pressure (CPAP) or BiPAP devices for sleep apnea is permitted. 11. 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 (7.3 kPa) * PaO2 \< 45 mm Hg (6.0 kPa) 12. Subject has pulmonary hypertension, defined as mean pulmonary systolic pressure \> 45 mm Hg. 13. Subject has known documented alpha-1 antitrypsin deficiency. 14. Subject has clinically significant hematological disorder. 15. 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. 16. Subject has non-atrial arrhythmias or conduction abnormalities on EKG. 17. 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), or serum creatinine \> 2.0 mg/dL (177 μmol/L). 18. Subject has uncontrolled exercise induced syncope. 19. 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. 20. 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. 21. Subject cannot tolerate corticosteroids or relevant antibiotics. 22. 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. 23. Subject use of immunosuppressive agents within four (4) weeks of the ICF signature date. Subjects may be re-considered for future enrollment. 24. 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. 25. Subject has allergy or sensitivity to medications required to safely perform bronchoscopy under conscious sedation or general anesthesia. 26. 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. 27. Subject is a female who is pregnant (positive βHCG Pregnancy test), breast-feeding, or planning to be pregnant in the next 12 months. 28. Subject has Body Mass Index \< 18 kg/m2 or \> 35 kg/m2. 29. 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.

Inclusion Criteria

Exclusion Criteria

1. Subject is willing and able to provide informed consent and to participate in the study.
2. Subject is aged ≥ 22 and ≤ 80 years at the time of the ICF signature date.
3. Subject has completed a documented pulmonary rehabilitation (in clinic or home-based) program within 6 months prior to Baseline.
4. Subject has stopped smoking for at least 8 weeks prior to the ICF signature date as confirmed by carboxyhemoglobin or cotinine levels.
5. Subject has an HRCT from the screening institution within 3 months of the ICF signature date with the following findings at -910 Hounsfield Units:
1. At least one (1) lobe with segmental emphysema destruction score ≥ 50%.
2. 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.
3. LUL, LLL, RUL, RLL, or RUL+RML are targets for valve intervention.
4. 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.
5. Subject has 98% of the fissure gap confined to a maximum of 3 segments within the target lobe per Fissure Targeting Report (FTR).
6. Subject has 6MWD ≥ 250 m and ≤ 450 m.
7. Subject has clinically significant dyspnea with an mMRC score of ≥ 2.
8. Subject has post-bronchodilation FEV1 ≥ 15% predicted and ≤ 45% predicted.
9. Subject has an FEV1/FVC ratio of \< 0.7.
10. Subject has post-bronchodilation TLC, measured by body plethysmography, ≥ 100% predicted.
11. Subject has post-bronchodilation RV ≥ 175% predicted, measured by body plethysmography.
12. Subject has post-bronchodilation DLCO ≥ 20% predicted.
13. Subject has received preventative vaccinations against potential respiratory infections, including COVID-19, consistent with local recommendation or policy.
14. Subject is on optimal medical management for more than one month prior to the ICF signature date.
15. Subject has collateral ventilation (CV+) as confirmed per the Chartis assessment prior to the AeriSeal Index Procedure.

1. 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.
2. 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).
3. Post-COVID-19 pathology on CT, including ground glass opacities with or without consolidation, adjacent pleura thickening, interlobular septal thickening, or air bronchograms.
4. Large bullae encompassing greater than 1/3 of the total lung.
5. 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.
6. Subject has asthma as their primary diagnosis.
7. Subject has chronic bronchitis (defined as greater than 4 tablespoons of sputum production per day) as their primary diagnosis.
8. Subject has clinically significant bronchiectasis.
9. Subjects with evidence of active respiratory infection should be considered for enrollment only after satisfactory resolution.
10. Subject requires invasive ventilatory support. Note: The use of Continuous Positive Airway Pressure (CPAP) or BiPAP devices for sleep apnea is permitted.
11. 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 (7.3 kPa)
* PaO2 \< 45 mm Hg (6.0 kPa)
12. Subject has pulmonary hypertension, defined as mean pulmonary systolic pressure \> 45 mm Hg.
13. Subject has known documented alpha-1 antitrypsin deficiency.
14. Subject has clinically significant hematological disorder.
15. 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.
16. Subject has non-atrial arrhythmias or conduction abnormalities on EKG.
17. 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), or serum creatinine \> 2.0 mg/dL (177 μmol/L).
18. Subject has uncontrolled exercise induced syncope.
19. 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.
20. 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.
21. Subject cannot tolerate corticosteroids or relevant antibiotics.
22. 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.
23. Subject use of immunosuppressive agents within four (4) weeks of the ICF signature date. Subjects may be re-considered for future enrollment.
24. 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.
25. Subject has allergy or sensitivity to medications required to safely perform bronchoscopy under conscious sedation or general anesthesia.
26. 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.
27. Subject is a female who is pregnant (positive βHCG Pregnancy test), breast-feeding, or planning to be pregnant in the next 12 months.
28. Subject has Body Mass Index \< 18 kg/m2 or \> 35 kg/m2.
29. 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.

Contacts and Locations

Study Contact

Christina Kutzavitch, PhD

CONTACT

+1 650-216-0134

ckutzavitch@pulmonx.com

Joshua Percy

CONTACT

+1 650-810-1420

jpercy@pulmonx.com

Principal Investigator

Anna K Gawlicka, PhD, MBA

STUDY_DIRECTOR

Pulmonx Corporation

Study Locations (Sites)

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Penn Medicine

Philadelphia, Pennsylvania, 19107

United States

Temple University

Philadelphia, Pennsylvania, 19140

United States

Collaborators and Investigators

Sponsor: Pulmonx Corporation

Anna K Gawlicka, PhD, MBA, STUDY_DIRECTOR, Pulmonx Corporation

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 Registration Dates

Study Start Date2024-02-22

Study Completion Date2028-03-31

Study Record Updates

Study Start Date2024-02-22

Study Completion Date2028-03-31

Terms related to this study

Keywords Provided by Researchers

Collateral Ventilation
Bronchoscopic Lung Volume Reduction
Hyperinflation

Additional Relevant MeSH Terms

Emphysema, Pulmonary
Emphysema or COPD