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About
The purpose of this study is to prospectively evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
Full description
This is a prospective single arm study to evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
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Volunteers
Inclusion criteria
Willing and able to provide informed consent and to participate in the study
Age > or = 40 years at the time of the screening
Advanced lower or lower and upper lobe predominant heterogeneous emphysema by CT scan
Minimum of 2 subsegments appropriate for treatment
MRCD questionnaire score of 2 or greater at screening
Failure of medical therapy to provide relief of symptoms
Spirometry 15 minutes after administration of bronchodilator (BOTH):
Lung volumes by plethysmography (BOTH):
Diffusing Capacity of Carbon Monoxide(DLco) > = 20 and < = 60 percent predicted
Oxygen saturation (SpO2) > 90 % on < or = 4 L/min supplemental O2, at rest
Six-Minute Walk Test distance > or = 150 m
Abstinence from smoking for at least 16 weeks prior to screening
Exclusion criteria
Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, or prior lung transplantation
Requirement for ventilator support (invasive or non-invasive)
Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks of Screening visit
Pulmonary hypertension, defined as:
Clinically significant asthma (reversible airway obstruction) or bronchiectasis
CT scan: Presence of the following radiologic abnormalities:
Use of systemic steroids > 20 mg/day or equivalent, immunosuppressive agents, heparins, oral anticoagulants (e.g., warfarin, dicumarol; note: antiplatelet drugs including aspirin and clopidogrel are permitted)
Allergy or sensitivity to medications required to safely undergo AeriSeal System treatment
Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the screening visit
Body mass index < 15 kg/m2 or > 35 kg/m2
Female patient pregnant or breast-feeding or planning to be pregnant in the next year
Significant comorbidity that carries prohibitive risks or is associated with less than 2-year expected survival, including any of the following:
Any condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient such as alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits
Primary purpose
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0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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