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Trial registered on ANZCTR


Registration number
ACTRN12616000972426
Ethics application status
Approved
Date submitted
18/07/2016
Date registered
25/07/2016
Date last updated
14/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
ARIA ETS (Emphysema Treatment System) Clinical Trial for patients with Severe Emphysema
Scientific title
A Non-Randomized Study to Evaluate the Safety and Performance of the ARIA Trademark Emphysema Treatment System in Patients with Severe Emphysema with Hyperinflation of the Lung
Secondary ID [1] 289680 0
Nil Secondary
Universal Trial Number (UTN)
Trial acronym
ARIA ETS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Emphysema 299481 0
Hyperinflation of the lung 299482 0
Condition category
Condition code
Respiratory 299461 299461 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Insertion of the ARIA Emphysema Treatment System (ETS) will occur during an approximate 60 minute thoracic surgery procedure. The ARIA ETS, which is a device that is secured in the lung and vents via a tube to the outside of the chest will remain implanted in the patient's chest for the duration of the trial (12months from implantation of device). The premise of the technology is that it reduces hyperinflation of the lung which leads to emphysematous symptoms. Implantation of the device, ongoing assessment and follow up will be performed in an accredited hospital providing tertiary thoracic surgery and respiratory medicine services. Tests required to participate in the study will include CT Scan, Respiratory Function Testing, Exercise Testing (Cycle and 6 Minute Walk Test), Blood tests and intermittent bronchoscopies via the ARIA ETS system.
Intervention code [1] 295303 0
Treatment: Devices
Comparator / control treatment
No Control Group - FIH Trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298944 0
Safety will be determined by the incidence of any serious adverse events reported either by the patient or observed by the investigator, relating to the procedure or to the device itself either perioperatively or in the follow-up period as determined by the Independent Medical Monitor. Adverse events that will be assessed may include (but not be limited to) exacerbations of COPD, device related events including pneumothorax and surgical emphysema (leakage of air into the chest cavity or under the skin) , bleeding from the chest wall or lung around the implant insertion site. These events will be assessed by clinical examination and may also include tests such as X-rays, CT scans and routine blood tests. All adverse events will be documented.
Timepoint [1] 298944 0
12 months from insertion of the ARIA ETS device.
Secondary outcome [1] 325717 0
Effectiveness outcomes to be evaluated in this study are:
Technical success. This will be assessed by successful placement of the device and the detection of airflow through the device
Timepoint [1] 325717 0
Upon insertion of device and prior to hospital disccharge
Secondary outcome [2] 325867 0
Lung and Lobar Volumes assessed by CT Scan
Timepoint [2] 325867 0
6 months from insertion of device
Secondary outcome [3] 325868 0
Pulmonary function test results as assessed by the performance of spirometry testing
Timepoint [3] 325868 0
3, 6 and 12 months from insertion of device
Secondary outcome [4] 325869 0
Exercise tolerance as measured by 6 minute walk test and cycle ergometry.
Timepoint [4] 325869 0
3, 6 and 12 months from insertion of device.
Secondary outcome [5] 325870 0
Health Indices Assessment as assessed by the completion of questionnaires such as SGRQ and EQ-5D.
Timepoint [5] 325870 0
3, 6 and 12 months from insertion of device.
Secondary outcome [6] 325902 0
Symptoms assessed using the modified Medical Research Council (mMRC) dyspnea survey and COPD Assessment Test Score (CATS)
Timepoint [6] 325902 0
3, 6 and 12 months from insertion of device.

Eligibility
Key inclusion criteria
Severe emphysema with hyperinflation of the lung
Candidate for general anaesthesia
FEV1 > 18% and < 45%
BMI < 31.1 (Men) and <32.3 (Women)
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sensitivity to Nitinol
Patient is on Lung Transplant Waiting List
Alpha 1 Antitrypsin deficiency
Significant bleeding risk
Known lung cancer or pulmonary nodules that require investigation

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/08/2016
Actual
28/09/2016
Date of last participant enrolment
Anticipated
Actual
8/11/2016
Date of last data collection
Anticipated
8/11/2017
Actual
Sample size
Target
30
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment hospital [1] 6168 0
The Alfred - Prahran
Recruitment hospital [2] 6169 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment outside Australia
Country [1] 8027 0
Germany
State/province [1] 8027 0

Funding & Sponsors
Funding source category [1] 294061 0
Commercial sector/Industry
Name [1] 294061 0
Soffio Medcial Inc.
Country [1] 294061 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Soffio Medical Inc.
Address
Soffio Medical, Inc.
745 Atlantic Avenue
Boston, MA 02111 United States of America
Country
United States of America
Secondary sponsor category [1] 292890 0
Commercial sector/Industry
Name [1] 292890 0
Soffio Medical Australia Pty Ltd
Address [1] 292890 0
Soffio Medical Australia Pty Ltd
10/120 Saunders St
Pyrmont NSW 2009 Australia
Sponsor
Country [1] 292890 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295474 0
Alfred Hospital Ethic Committee
Ethics committee address [1] 295474 0
Ethics committee country [1] 295474 0
Australia
Date submitted for ethics approval [1] 295474 0
29/02/2016
Approval date [1] 295474 0
30/05/2016
Ethics approval number [1] 295474 0
49/16

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67422 0
A/Prof Gregory Snell
Address 67422 0
Alfred Hospital
55 Commercial Road
Melbourne, VICTORIA 3004
Country 67422 0
Australia
Phone 67422 0
+ 61 03 9076 2867
Fax 67422 0
+ 61 03 9076 3601
Email 67422 0
G.Snell@alfred.org.au
Contact person for public queries
Name 67423 0
Lynda Holsworth
Address 67423 0
Alfred Hospital
55 Commercial Road
Melbourne, VICTORIA 3004
Country 67423 0
Australia
Phone 67423 0
+ 61 03 9076 2743
Fax 67423 0
+ 61 03 9076 3601
Email 67423 0
L.Holsworth@alfred.org.au
Contact person for scientific queries
Name 67424 0
Annette Fagnant
Address 67424 0
745 Atlantic Avenue
Boston, MA USA 02111
Country 67424 0
United States of America
Phone 67424 0
+ 1 401 439 6311
Fax 67424 0
+ 1 401 397 6531
Email 67424 0
annette@soffiomedical.com

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
No additional documents have been identified.