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New treatment option for Emphysema, Pulmonary
Official title An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema
ClinicalTrials.gov ID: NCT06035120
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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...
You likely can't join if
- Subject has prior lung volume reduction surgery, lobectomy or pneumonectomy, lung transplantation, airway stent placement, pleurodesis, or BLVR of...
- 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...
- Post-COVID-19 pathology on CT, including ground glass opacities with or without consolidation, adjacent pleura thickening, interlobular septal...
- 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...
- Subject has asthma as their primary diagnosis.
See the full eligibility criteria
Who can 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%.
- 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...
- 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.
What rules you out
- 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 \ 6 months prior to ICF...
- 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)...
- 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. people may...
- Subject has asthma as their primary diagnosis.
- Subject has chronic bronchitis (defined as greater than 4 tablespoons of sputum production per day) as their primary diagnosis.
- Subject has clinically significant bronchiectasis.
- people 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...
- 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...
- 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. people may be re-considered for future enrollment.
- Subject use of immunosuppressive agents within four (4) weeks of the ICF signature date. people 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...
- 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 \ 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: people being followed as part of a long-term...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Hartford, Connecticut, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Peoria, Illinois, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Knoxville, Tennessee, United States
- Dallas, Texas, United States
- Falls Church, Virginia, United States
- Milwaukee, Wisconsin, United States
- Adelaide, Australia, Australia
- Brisbane, Australia, Australia
- Macquarie Park, Australia, Australia
- Vienna, Austria, Austria
- Copenhagen, Denmark, Denmark
- Limoges, France, France
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Hartford, Connecticut, United States; Orlando, Florida, United States; Chicago, Illinois, United States; Peoria, Illinois, United States; Boston, Massachusetts, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.