A Multicenter, Prospective, Single-Arm Clinical Investigation of a Modified Staged Treatment Algorithm using the AeriSeal system
- Conditions
- COPDEmphysema10038716
- Registration Number
- NL-OMON42867
- Lead Sponsor
- Pulmonx International Sarl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
1. Subject is willing and able to provide informed consent and to participate in the study.
2. Subject is >= 40 years of age.
3. Subject has a diagnosis of homogenous or heterogeneous upper lobe predominant emphysema confirmed by CT scan.
4. Subject has at least 2 non-adjacent subsegments appropriate for treatment based upon CT scan in 2 different upper lobe segments in each lung (total 4 available subsegments)
5. Subject has clinically significant dyspnea scoring >= 1 on the mMRC scale of 0 - 4
6. Subject has a Six-Minute Walk Test (6MWT) distance >= 250 meters
7. Subject has post-bronchodilator FEV1 <= 45% predicted
8. Subject has Total Lung Capacity >100% predicted
9. Subject has Residual Volume >= 175% predicted
10. Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by carboxyhemoglobin or cotinine levels.
11. Subject has received preventive vaccinations against potential respiratory infections consistent with local recommendations or policy.
1. Subject has severe bullous emphysema as judged by the Investigator.
2. Subject has prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
3. Subject has evidence of active respiratory infection
4. Subject has an ongoing COPD exacerbation or bronchospasm
5. Subject has a known allergy to the device components:
a. Polyether block amide - PEBAX®
b. Polyvinyl Alcohol
c. Glutaraldehyde
6. Subject requires ventilatory support (invasive or non-invasive)
7. Subject has DLco < 20% predicted
8. Subject has a post-bronchodilator FEV1 < 20% predicted
9. Subject cannot tolerate corticosteroids or relevant antibiotics
10. Subject has other relevant comorbidities as judged by the Investigator, or is deconditioned and cannot tolerate the stress of post-treatment inflammatory response;
11. Subject has a history of recurrent clinically significant respiratory infections, defined as three (3) or more COPD exacerbations requiring hospitalization during the year prior to enrollment.
12. Subject has severe gas exchange abnormalities as defined by any one of the following:
a. PaCO2 >55 mm Hg
b. PaO2 <45 mm Hg on room air
c. SpO2 < 90% on >= 4 L/min supplemental O2, at rest
13. Subject has Pulmonary hypertension, defined as peak systolic pressure > 45 mm Hg on echocardiogram or right heart catheterization.
14. Subject 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) within 4 weeks of entering the study.
15. Subject has alpha1 -antitrypsin serum level of <80 mg/kg (i.e. < 11 µmol/L) at Screening
16. Subject*s CT scan indicates the presence of any the following radiologic abnormalities:
a. Pulmonary nodule on CT scan greater than 0.8 cm in diameter (Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/PET)
b. Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate
c. Significant interstitial lung disease
d. Significant pleural disease
17. Subject*s baseline EKG indicates arrhythmias or conduction abnormalities.
18. 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 :
19. Clinically significant asthma (reversible airway obstruction), chronic bronchitis, or bronchiectasis.
20. Allergy or sensitivity to medications required to safely perform bronchoscopy and the AeriSeal System treatment under general anesthesia or conscious sedation.
21. Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to entering the study or planned during the course of the study.
22. Body mass index (BMI) < 15 kg/m2 or > 35 kg/m2
23. Female subject pregnant or breast-feeding.
24. Abnormal screening laboratory test results as compared to reference lab normals at individual sites as follows:
a. Blood urea nitrogen > 1.5 x upper limit of normal
b. Creatinine > 1.5 x upper limit of normal
c. Aspartate aminotransf
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. The primary endpoint will be safety of AeriSeal System treatment. Safety<br /><br>will be assessed by monitoring the incidence of Serious Adverse Events (SAEs),<br /><br>during the 3*months post treatment period. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Percent mean change relative to baseline at 3-months, 6-months and 12-months<br /><br>for:<br /><br>a. Forced Expiratory Volume in one second (FEV1)<br /><br>b. Residual volume (RV)<br /><br>2. Absolute change relative to baseline at 3-months, 6-months and 12-months for:<br /><br>a. Exercise capacity as assessed by six*minute walk test (6MWT)<br /><br>b. Quality of life as assessed by the St George*s Respiratory Questionnaire<br /><br>(SGRQ)<br /><br>c. Dyspnea as assessed by the Modified Medical Research Council Dyspnea Score<br /><br>(mMRC)<br /><br>3. Lobar volume reduction of the treated lobes as quantified by CT scans at<br /><br>3-months.<br /><br>4. Radiological signs on CT scans of complications including but not limited to<br /><br>pneumonias, pleural effusions and consolidation at, and outside the treatment<br /><br>sites and formation of lung abscesses at 3-months following the second<br /><br>placement of AeriSeal foam.</p><br>