Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000190000
Ethics application status
Approved
Date submitted
27/02/2010
Date registered
3/03/2010
Date last updated
9/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Portaero Pneumostoma System in Patients with Severe Emphysema and Hyperinflation of the Lung
Scientific title
A Non-randomized Study to Evaluate the Safety and Performance of the Portaero Pneumostoma System in Patients with Severe Emphysema and Hyperinflation of the Lung
Secondary ID [1] 1444 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 256892 0
Condition category
Condition code
Respiratory 257040 257040 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The surgical device kit of the Portaero System creates a pneumonostomy channel through a minimally-invasive transthoracic surgical approach. The procedure is a single session event that takes approximately 1 hour to complete.
Intervention code [1] 256088 0
Treatment: Devices
Intervention code [2] 256101 0
Treatment: Surgery
Comparator / control treatment
There is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257929 0
Change in Forced Expiratory Volume in 1 second (FEV1) of greater than or equal to 12% (FEV1>= 12%) from baseline
Timepoint [1] 257929 0
Baseline, 3 and 6 Months after intervention
Primary outcome [2] 257930 0
Decrease in Saint George's Respiratory Questionnaire (SGRQ)(total) of 4 points or more from baseline
Timepoint [2] 257930 0
Baseline, 3 and 6 Months after intervention
Secondary outcome [1] 263413 0
Lung function status by Forced Vital Capacity (FVC), Residual Volume (RV), Residual Volume to Total Lung Capacity ratio (RV/TLC)
Timepoint [1] 263413 0
Baseline, 3 and 6 Months after intervention
Secondary outcome [2] 263414 0
Lung Volume Computerized Tomography (CT) Scan results
Timepoint [2] 263414 0
Baseline, 3 and 6 Months after intervention
Secondary outcome [3] 263415 0
Exercise tolerance as measured by 6 minute walk test (6MWT) and Cycle Ergometry test
Timepoint [3] 263415 0
Baseline, 3 and 6 Months after intervention
Secondary outcome [4] 263416 0
Dyspnea evaluation by Modified Medical Research Council (mMRC) Dyspnea scores
Timepoint [4] 263416 0
Baseline, 3 and 6 Months after intervention
Secondary outcome [5] 263417 0
Quality of Life as assesssed by EQ-5D questionnaire
Timepoint [5] 263417 0
Baseline, 3 and 6 Months after intervention

Eligibility
Key inclusion criteria
1. CT scan consistent with severe emphysema grade >= 2 (per National Emphysema Treatment Trial (NETT) ) involving both ipsilateral upper and lower lobes
2. Airflow obstruction as evidenced by Forced Expiratory Volume in 1 second (FEV1) to Forced Vital Capacity ratio (FEV1/FVC)< 70% post-bronchodilator
3. Patients with FEV1>20% and <45% of predicted post bronchodilator
4. Patient with hyperinflation defined as:
a. Residual Volume (RV)> 150% of predicted post bronchodilator
b. Total Lung Capacity (TLC)>100% post bronchodilator
5. Arterial blood or arterialized blood gas results of:
a. Partial Pressure of Oxygen in Arterial Blood (PaO2) >= 45 mmHg breathing room air
b. Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)< 60 mmHg breathing room air
6. Transfer Factor of Carbon Monoxide (TLco) > 20% predicted
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Six minute walk test distance (6MWT) < 140m after completing pulmonary rehabilitation
2. Clinically significant daily sputum production or bronchiectasis
3. Patient experienced 3 or more exacerbations of COPD requiring hospitalization over previous 12 months
4. Patient is currently using domiciliary noninvasive ventilation (NIV) with the exception of continuous positive airway pressure (CPAP) or biphasic positive airway pressure for the treatment of obstructive sleep apnea (OSA)
5. Patient with chest infection within 30 days prior to procedure (NOTE: After meeting eligibility and patient develops chest infection with 30 days prior to procedure, patient must wait a minimum of 45 days or until infection is resolved.)
6. Body Mass Index (BMI) < 17 or >31
7. Patient with uncontrolled hypertension, defined as blood pressure > 200/110 mmHg
8. Patient with Cerebrovascular accident (CVA) within last 12 months
9. Patient with severe pulmonary hypertention defined as Right Ventricular End Systolic Pressure (RVESP)>= 49 mmHg by echocardiography at Screening (or documented Right Ventricular Systolic Pressure (RVSP)> 45 mmHg by Right Heart Catheterization (RHC))
10. Patient with Myocardial Infarction (MI) within 6 months, Left Ventricular Ejection Fraction (LVEF)<45% or any other cardiac condition/arrhythmia that posses an anesthetic risk
11. Patient with bleeding risk, i.e., abnormal clotting, anticoagulants that cannot be ceased peri-operatively, or thrombocytopenia (platelet count < 100 X 10^3/micro liters)
12. Patient with known Alpha-1 antitrypsin deficiency
13. Patient who underwent previous ipsilateral Lung Volume Resection Surgery (LVRS), lobectomy or pleural surgery.
14. Patient has giant bulla that occupy more than >1/3 volume of lung
15. Patient has known lung cancer or pulmonary nodule(s) that require investigation
16. Patient is currently being treated with high dose corticosteroids (defined as > 10mg/day prednisone or equivalent) for a total of more than 30 days within the past 2 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2603 0
6009, 3004
Recruitment outside Australia
Country [1] 2526 0
Austria
State/province [1] 2526 0
Wien
Country [2] 2527 0
Germany
State/province [2] 2527 0
Essen, Heidelberg
Country [3] 2528 0
United Kingdom
State/province [3] 2528 0
London
Country [4] 2529 0
Netherlands
State/province [4] 2529 0
Groningen

Funding & Sponsors
Funding source category [1] 256580 0
Commercial sector/Industry
Name [1] 256580 0
Portaero, Inc.
Country [1] 256580 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Portaero, Inc.
Address
21631A Stevens Creek Boulevard
Cupertino, CA 95014-1169
Country
United States of America
Secondary sponsor category [1] 255875 0
None
Name [1] 255875 0
Address [1] 255875 0
Country [1] 255875 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258613 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 258613 0
Hospital Ave
Nedlands, WA 6009
Ethics committee country [1] 258613 0
Australia
Date submitted for ethics approval [1] 258613 0
Approval date [1] 258613 0
01/10/2009
Ethics approval number [1] 258613 0
2009-105

Summary
Brief summary
This is the second trial to evaluate the safety and performance of the Portaero Pneumostoma System in patients with severe emphysema and hyperinflation of the lung.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30885 0
Address 30885 0
Country 30885 0
Phone 30885 0
Fax 30885 0
Email 30885 0
Contact person for public queries
Name 14132 0
Ya-Chen Hsu
Address 14132 0
Portaero, Inc.
21631A Stevens Creek Boulevard
Cupertino, CA 95014-1169
Country 14132 0
United States of America
Phone 14132 0
+1.408.777.8687
Fax 14132 0
Email 14132 0
[email protected]
Contact person for scientific queries
Name 5060 0
Don Tanaka
Address 5060 0
Portaero, Inc.
21631A Stevens Creek Boulevard
Cupertino, CA 95014-1169
Country 5060 0
United States of America
Phone 5060 0
+1.408.777.8687
Fax 5060 0
Email 5060 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe fissure: interlobar collateral ventilation and implications for endoscopic therapy in emphysema2016https://doi.org/10.2147/copd.s103807
EmbaseFeasibility and Safety of a Transthoracic Pneumostoma Airway Bypass in Severe Emphysema Patients.2017https://dx.doi.org/10.1159/000455878
N.B. These documents automatically identified may not have been verified by the study sponsor.