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NCT05396131 | COMPLETED | Chronic Obstructive Pulmonary Disease (COPD)

The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR Utilizing Endobronchial Valves.
Sponsor:

Macquarie University, Australia

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 has two arms; arm 1 is for CV positive participants who will receive the lung sealant and EBV; arm 2 is the CV negative group who will only receive EBV as the standard management.

Condition or disease

Chronic Obstructive Pulmonary Disease (COPD)

Intervention/treatment

Lung Sealant

Endobronchial Valve (EBV)

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 16 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR (Endoscopic Lung Volume Reduction) Utilizing Endobronchial Valves
Actual Study Start Date : 2019-06-20
Estimated Primary Completion Date : 2022-01-07
Estimated Study Completion Date : 2022-01-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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 Criteria
  • * 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.
The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR Utilizing Endobronchial Valves.

Location Details

NCT05396131

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Australia, New South Wales

Macquarie University

Macquarie Park, New South Wales, Australia, 2109