Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000408381
Ethics application status
Approved
Date submitted
31/07/2008
Date registered
19/08/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transthoracic Pneumonostomy System for Severe Emphysema
Scientific title
Evaluation of the Safety and Feasiblity of the Portaero System Used in Transthoracic Pneumonostomy Procedure to Treat Patients With Homogeneous Emphysema
Secondary ID [1] 666 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) 3488 0
Condition category
Condition code
Respiratory 3643 3643 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 up to 1 hour to complete.
Intervention code [1] 3211 0
Treatment: Devices
Comparator / control treatment
There is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4570 0
Descriptive statistics analysis on the incidence of complications and adverse events (serious and non-serious). Variables will be summarized by frequencies and percentages.
Timepoint [1] 4570 0
Pre-procedure through 6 months after intervention
Secondary outcome [1] 7689 0
Lung function status as measured by Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), and Residual Volume (RV)
Timepoint [1] 7689 0
Baseline and 1, 2, 3, and 6 months after intervention
Secondary outcome [2] 7690 0
Preliminary EQ-5D comparison for cost-effectiveness analysis
Timepoint [2] 7690 0
Baseline and 1, 2, 3 and 6 months after intervention
Secondary outcome [3] 7691 0
Exercise tolerance as measured by 6 minute walk test (6MWT) and Cycle Ergometry test
Timepoint [3] 7691 0
Baseline and 1, 2, 3, and 6 months after intervention
Secondary outcome [4] 7725 0
Quality of Life as assessed by St. George's Respiratory Questionnaire (SGRQ)
Timepoint [4] 7725 0
Baseline and 1, 2, 3, and 6 months after intervention

Eligibility
Key inclusion criteria
1. CT (computed tomography) scan consistent with severe emphysema grade of greater than or equal to 2 (per NETT, National Emphysema Treatment Trial) involving both ipsilateral upper and lower lobes

2. Airflow obstruction as evidenced by FEV1/FVC ratio (Forced Expiratory Volume in the first second/Forced Vital Capacity ratio) < 70% post-bronchodilator

3. Patients with FEV1 > 20% and < 45% of predicted post bronchodilator

4. Patient with hyperinflation defined as
a) RV (Residual Volume) > 150% of predicted post bronchodilator
b) TLC (Total Lung Capacity) > 100% post bronchodilator
Minimum age
45 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. PaCO2 (pressure of carbon dioxide) > 60mm Hg breathing room air

2. 6 minute walk test distance (6MWT) < 140m after completing pulmonary rehabilitation

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. BMI (body mass index) < 17 or > 31

6. Patient with uncontrolled hypertension, defined as blood pressure > 200/110 mmHg

7. Patient with severe pulmonary hypertension defined as RVESP (right ventricular end systolic pressure) = 49 mmHg by echocardiography at Screening (or documented RVSP (right ventricular systolic pressure) > 45 mmHg by right heart catheterization)

8. Patient with myocardial infarction within 6 months, LVEF (left ventricular ejection fraction) < 45% or any other cardiac condition / arrhythmia that poses an anesthetic risk

9. Patient with bleeding risk, i.e., abnormal clotting, anticoagulants that cannot be ceased peri-operatively, or thrombocytopenia (platelet count < 100 X 103/µL )

10. Patient with known a-1 antitrypsin deficiency

11. Patient who underwent previous ipsilateral LVRS (lung volume reduction surgery), lobectomy or pleural surgery.

12. Patient has giant bulla that occupy more than >1/3 volume of lung

13. Patient has known lung cancer or pulmonary nodule(s) that require investigation

14. Patient is currently being treated with high dose corticosteroids defined as > 10mg/day prednisone or equivalent

15. Female patient with positive HCG (human chorionic gonadotropin) pregnancy test at Screening.

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/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/08/2008
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] 1044 0
6009
Recruitment postcode(s) [2] 1045 0
3004
Recruitment outside Australia
Country [1] 1094 0
Germany
State/province [1] 1094 0
Hamburg, Essen, and Heidelberg
Country [2] 1095 0
United Kingdom
State/province [2] 1095 0
London

Funding & Sponsors
Funding source category [1] 3664 0
Commercial sector/Industry
Name [1] 3664 0
Portaero, Inc.
Country [1] 3664 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] 3292 0
None
Name [1] 3292 0
Address [1] 3292 0
Country [1] 3292 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5738 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 5738 0
Hospital Avenue
Nedlands
Western Australia 6009
Ethics committee country [1] 5738 0
Australia
Date submitted for ethics approval [1] 5738 0
Approval date [1] 5738 0
27/03/2008
Ethics approval number [1] 5738 0
2007-192

Summary
Brief summary
The primary objective of this study is to evaluate and determine the types of complications and benefits from the transthoracic pneumonostomy procedure in patients with severe emphysema (homogeneous). The results from this study will provide the profile for safety and feasibility of use of the pneumonostomy device system and support subsequnt trials with larger number of patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28795 0
Address 28795 0
Country 28795 0
Phone 28795 0
Fax 28795 0
Email 28795 0
Contact person for public queries
Name 11952 0
Ya-Chen Hsu
Address 11952 0
Portaero, Inc.
21631A Stevens Creek Boulevard
Cupertino, CA 95014-1169
Country 11952 0
United States of America
Phone 11952 0
+1.408.777.8687
Fax 11952 0
Email 11952 0
[email protected]
Contact person for scientific queries
Name 2880 0
Don Tanaka
Address 2880 0
Portaero, Inc.
21631A Stevens Creek Boulevard
Cupertino, CA 95014-1169
Country 2880 0
United States of America
Phone 2880 0
+1.408.777.8687
Fax 2880 0
Email 2880 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
EmbaseTransthoracic pneumonostomy - Effect on lung volume and mechanics.2011https://dx.doi.org/10.1111/j.1440-1843.2011.01937.x
N.B. These documents automatically identified may not have been verified by the study sponsor.