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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collateral Ventilation Negative | Active Comparator | Collateral Ventilation Negative participants will have endobronchial valve implant |
|
| Collateral Ventilation Positive | Experimental | Collateral Ventilation Positive participants will have the lung sealant applied and the endobronchial valve implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung Sealant | Device | The Aeriseal System uses a polymer foam to block or seal fissures, peripheral airways, alveoli, and collateral channels to achieve lung volume reduction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-) | Collateral ventilation status will be functionally assessed and confirmed via CHARTIS® System. Examination of left upper lobe to determine percentage of participants converted from collateral ventilation positive to a collateral ventilation negative state | 4 weeks post lung sealant application |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with improved lung functioning as measured by lung function tests | Lung function will be assessed by spirometry, plethysmography, lung diffusion capacity and capillary blood test | 12weeks and 52 weeks post valve implant |
| Changes Lung volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alvin J Ing, MBBS, MD, FRACP | Clinical Professor and Respiratory Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macquarie University | Macquarie Park | New South Wales | 2109 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35918295 | Derived | Ing AJ, Jayapadman A, Kim WV, Ly C, Ho-Shon K, Lilburn P, Carew A, Ng BJH, Saghaie T, Williamson JP. Reversal of collateral ventilation using endoscopic polymer foam in COPD patients undergoing endoscopic lung volume reduction with endobronchial valves: A controlled parallel group trial. Respirology. 2022 Dec;27(12):1064-1072. doi: 10.1111/resp.14338. Epub 2022 Aug 2. |
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Participants diagnosed as either Collateral Ventilation (CV) Negative or CV Positive.
CV Negative participants will only receive the endobronchial valves (EBV). CV Positive participants will receive both the lung sealant and the EBV.
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|
| Endobronchial Valve (EBV) | Device | The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation. |
|
|
Changes in lung volume will be assessed using high resolution computed tomography (HRCT) and target lobe volume reduction (TLVR) |
| 12weeks and 52 weeks post valve implant |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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