Status:
COMPLETED
The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR Utilizing Endobronchial Valves.
Lead Sponsor:
Macquarie University, Australia
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The aim of this study is to determine the feasibility of combining a lung sealant with endobronchial valves EBV in managing patients with COPD who are collateral ventilation (CV) positive. This study ...
Eligibility Criteria
Inclusion
- i. 18-85 years of age
- ii. Forced Expiratory Volume in 1second (FEV1) 20 - 50%
- iii. Residual Volume (RV) \> 175%
- iv. 6 min walk test \> 150 m
- v. Completed a course of Pulmonary rehabilitation
- vi. STRATX assessment - Left Upper Lobe as the most appropriate lobe to target for ELVR
- vii. This study will be investigating heterogenous emphysema only. Minimum of 15% differential in emphysema destruction scores at -950 HU
Exclusion
- i. Acute uncontrolled medical illness including ischemic heart disease, cardiac failure, acute renal impairment
- ii. Acute respiratory tract infections
- iii. Significant bronchiectasis,
- iv. Co-existing interstitial lung diseases, pneumothorax,
- v. Known active malignancy
- vi. Pregnancy.
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05396131
Start Date
June 20 2019
End Date
January 7 2022
Last Update
May 31 2022
Active Locations (1)
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1
Macquarie University
Macquarie Park, New South Wales, Australia, 2109